Career Opportunities at IQVIA

We are looking for a dedicated Client Services Lead located in Bloemfontein, South Africa, to be part of the Clinical Trial Payments unit in IQVIA. This position will have the option to work fully remote or from the office. This position will work as part of the Clinical Trial Payments unit. It uses the most advanced site payment solution available and offers service to customers to integrate/centralize all payments in a high tech software. The Client Services Lead is responsible for ensuring clients obtain maximum value from products and services in order to facilitate a positive and productive long-term relationship, either broad client or offering focused.

• Ensures fulfillment of contract specifications and ad-hoc client requests to build client satisfaction, under supervision.
• Assists team members to build, establish and maintain effective business relationships with clients to proactively support their needs as their day-to-day contact, possibly focused on a specific product or service.
• Ensures, through review and verification, that the product deliverable meets the customer's specifications, including timeliness and quality.
• Partners with the account manager and clients to derive optimum value from IQVIA products and services by explaining and expanding the usage of current IQVIA deliverables and identifying revenue opportunities within existing clients.
• Maintains effective internal communications with sales and client service support to keep all apprised on activities with the client.
• Monitors performance against existing service agreements and ensures client’s obligations are met.
• Researches, analyzes and responds to client that require an in-depth understanding of the client, specific business line, and/or therapeutic market.
• May conduct product/services and process training for clients and other employees.
• May conduct service meetings at client sites.
• May mentor and lead other client service reps and represent the manager in their absence.

Experience and Qualification:

• Bachelor's Degree required.
• + 4 years of related work experience in finance, banking or project management.
• Proficiency in Office tools applications, such as Excel and Power Point.
• Fluent English skills is a must and any other language will be considered as a plus.
• Broad knowledge of the concepts, practices and procedures of the client service representative field.
• Ability to communicate effectively with various levels in the organization (written and oral) and to manipulate large transactional databases.
• Demonstrated problem solving, analytical and strong customer service skills.
• Knowledge of the pharmaceutical, CRO, life sciences or healthcare industry will be considered as a plus.

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• As a PMA you will work in partnership with the Project Leader/ Clinical Project Manager in one of our Single Sponsor Delivery Units as well as our specialist therapeutic areas: Internal Medicine, Central Nervous System, Gastroenterology Immunology & Women’s Heath, Cardiovascular Renal Metabolic, Early Clinical Development or Oncology.
• Your key purpose will be to support with project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned projects.

Essential Functions

• Establish and manage performance dashboards, analyse event triggers/alerts and determine appropriate follow up for Project Leader or other functions
• Coordinate project schedule and ensure timely updates of all key milestone and partner with Project Leader on related calls
• Coordinate and support the risk and issue management process
• Manage all aspects of the Project Finances including Estimate at Completion (EAC), monthly expenses, invoices and reconciliation
• Demonstrate compliance with the Vendor and Purchase Order (PO) Management process
• Implement and maintain baseline and change control processes.
• Ensure Project Leader has timely and accurate data on areas including cost, schedule, scope, utilization, change orders and quality to support better decision-making
• Develop and maintain relevant sections of Project Management Plans
• Review and support project resource allocation within project budgeted for assigned portfolio/ projects
• Prepare correspondence, project status reports and presentation materials for project team and customer meetings
• Manage and coordinate core file reviews and support audits as needed. Drive e Trial Master File (eTMF) filing compliance focusing on completeness, timeliness and quality

Qualifications and Experience Required

• Bachelor's Degree in Life Sciences (or other related field)
• Minimum 1 year of relevant experience within analytical/financial field, ideally within clinical research
• Knowledge of clinical trials is advantageous
• An interest in life sciences, clinical research and/or patient health
• Previous exposure to working in a global environment
• Strong written and verbal communication skills including good command of English language
• Planning, time management and prioritization skills, the ability to problem solving skills with excellent attention to detail
• IT skills: good knowledge of Microsoft Office applications, including but not limited to, Microsoft Word, Excel, and PowerPoint

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IQVIA Biotech

• Our Clinical Project Managers are an integral part of the Biotech project management team, responsible for project delivery of clinical studies to meet contractual requirements focusing on leveraging therapeutic expertise in Oncology. Offering IQVIA Biotech’s suite of solutions to drive operational excellence and strategic leadership with our customers.

Responsibilities:

• Participate in bid defence presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.

Qualifications and Experience Required:

• Requires greater than 5 years of prior relevant experience including > 3 years project management experience
• Bachelor's Degree Life sciences or in a related field
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired.
• Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
• Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Planning, time management and prioritization skills.
• Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
• Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Finances - Good understanding of project financials (Bid defence meetings and managing contractual obligations and implications)
• Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

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BASIC FUNCTIONS:

• Lead/Senior Lead Clinical Data Manager position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manages DM-related aspects of the program and/or project
• Collaborates with the project team on overall data management strategy for the program and/or projects, assuring overall quality and efficiency
• Represent DM as the functional lead at internal and sponsor project team meetings
• Provides proactive, timely communication of project status, data trends and issue resolution with internal team and Sponsor
• Develops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor
• Assumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines and providing resource and budget projections
• Discusses roadblocks to DM deliverables and potential strategies for overcoming with project team and/or DM management and implements solutions
• Performs peer reviews of key DM study documents or other DM deliverables to assure quality of content and, where appropriate, consistency across a program of studies
• Reviews and provides DM staffing projections for program and/or projects
• Presents EDC and/or CRF completion at Investigator Meetings
• Participates in regulatory and Sponsor audits for program and/or projects
• Oversees daily team member activities
• Serves as a Data Management team leader
• Reviews DM team member activities and deliverables to ensure plans and processes are followed
• Assures project activities are performed within budget and according to expected timelines and meet high quality standards.
• Reviews resource allocation with the assigned DM project leads to ensure projects and budgets are managed effectively
• Provides training of DM staff on project specific processes
• Oversees the DM project and/or program team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans
• Oversees System Development and Modifications
• Oversees System and Data Listing Testing Activities
• Develops, Maintains and Archives DM Project Documentation
• Represents Data Management at Bid Defense Meetings (BDM)
• Continuous improvement

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to collaborate and strategize with both technical and clinical team members (CRAs, Safety, Biostatistics, etc)
• Ability to effectively communicate technical issues to non-DM team members and Sponsor
• Ability to maintain positive and open relations with internal, sponsor, and vendor team members
• Ability to facilitate team meetings ensuring accurate attendees and take meeting minutes
• Ability to develop study-specific procedures
• Knowledge of clinical trials concepts
• Ability to create detailed DM project instructions and documents (CRF Completion Guidelines, Database design documents, edit check specifications, Data Review Plan, etc.)
• Proficiency with multiple clinical EDC systems (preferred systems are InForm and Rave)
• Proficiency with IQVIA Biotech SOPs, WPs
• Efficient with organizational skills to meet established timelines
• Organized and thorough with attention to details
• Proficiency in computer applications and time management tools (e.g., MS Office)

MINIMUM RECRUITMENT STANDARDS:

• Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification

7 years of experience in clinical trials within a similar function, including:

• proven competence in managing delivery of multiple projects / programs independently through full data management study life-cycle
• Proven Lead experience
• experience in handling bid defense meetings
• Equivalent combination of education, training and experience

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• We are looking for a dedicated Client Services Manager located anywhere in Europe to be part of the Clinical Trial Payments unit in IQVIA. The Clinical Trial Payments department uses the most advanced site payment solution available and offers service to customers to integrate/centralize all payments in a high tech software.
• This position manages a group of client service professionals within a part of a large or mid-sized market or an assigned group. The Manager, Client Services is mainly responsible for quality and service to client, ensuring client obtains maximum value from products and services.

Essential Functions:

• Manages a staff of client service professionals, providing direction and guidance and developmental opportunities.
• Partners with clients to derive optimal value from IQVIA services, ensuring a seamless flow of client requirements through the delivery services process.
• Serves as project leader between the client and IQVIA – translates client needs into action plans with the internal service team (i.e. determines responsibilities and timeframes and negotiates resources with internal departments).
• Creates, maintains and monitors the client service agreement across business lines, ensuring consistency in service.
• Performs full assessments of client needs on a regular basis.
• Partners with account management to price products.
• May provide input into local client service strategy.

Requirements:

• Bachelor's Degree in Business Administration, Finance, Economics or similar.
• Five (5) years of relevant work experience.
• Proficient in Microsoft Office applications, specially Excel and Power Point.
• Business acumen (knowledge of the pharmaceutical industry would be considered as a plus).
• Experience developing and delivering training to clients.
• Change management/process analysis skills.
• Strong communication skills, including ability to train, present and deal tactfully with clients.
• Project management experience in overseeing or contributing in difficult, multi-discipline projects.
• Managerial skills, including a strong focus on team building.

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The role includes being part of the core project team responsible for clinical delivery and oversight of complex, global full service, multi-regional studies or a program of studies to meet contractual requirements and in accordance with SOPs, policies and practices. You will leverage therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers and focus on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction.

• Contribute to the development of the project delivery strategy for RFPs. Participate in bid defense preparations. Lead bid defense presentations in partnership with business development for large, complex, multi-service, multi-region studies or programs. Understand project strategy and operationalise the agreed upon approach.
• Oversee the development of integrated study management plans with the core project team
• Oversee the execution of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures
• Recognize systemic issues at the program or portfolio level and identify solutions with the project teams, recommend actions to improve efficiencies and oversee the implementation of best practices, address escalation items with the customer
• Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles
• Oversee progress against contract and prepare/present project information proactively to all stakeholders internally and externally
• Responsible for the oversight and team management of large and complex studies or programs of studies
• Responsible for portfolio management with one customer or therapeutic area
• Manage strategic risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans
• Drive consistency of operational delivery across customer’s projects/programs/portfolio
• Build the cross-functional program/portfolio team and lead their efforts
• Responsible for ensuring the financial success of programs/portfolio
• Forecast and identify opportunities to accelerate activities to bring revenue forward
• Identify and communicate strategic lessons learned and best practices to promote continuous improvement

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor's Degree Life sciences or related field with 15 years clinical research experience including 10 years of project management experience
• Proven people management skills. Ability to manage a global team of Project Leaders (20+) to deliver results as well as mentoring, training and coaching
• Strong leadership competencies and viewed as a leading expert within the field by peers
• Extensive knowledge of multiple job areas obtained through advanced education and experience
• Solid knowledge of clinical trials: broad protocol knowledge, therapeutic knowledge, clinical trial conduct, understanding of the competitive environment and how to communicate/demonstrate value

go to method of application »

The role includes being part of the core project team responsible for clinical delivery and oversight of complex, global full service, multi-regional studies or a program of studies to meet contractual requirements and in accordance with SOPs, policies and practices. You will leverage therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers and focus on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction.

• Contribute to the development of the project delivery strategy for RFPs. Participate in bid defense preparations. Lead bid defense presentations in partnership with business development for large, complex, multi-service, multi-region studies or programs. Understand project strategy and operationalise the agreed upon approach.
• Oversee the development of integrated study management plans with the core project team
• Oversee the execution of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures
• Recognize systemic issues at the program or portfolio level and identify solutions with the project teams, recommend actions to improve efficiencies and oversee the implementation of best practices, address escalation items with the customer
• Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles
• Oversee progress against contract and prepare/present project information proactively to all stakeholders internally and externally
• Responsible for the oversight and team management of large and complex studies or programs of studies
• Responsible for portfolio management with one customer or therapeutic area
• Manage strategic risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans
• Drive consistency of operational delivery across customer’s projects/programs/portfolio
• Build the cross-functional program/portfolio team and lead their efforts
• Responsible for ensuring the financial success of programs/portfolio
• Forecast and identify opportunities to accelerate activities to bring revenue forward
• Identify and communicate strategic lessons learned and best practices to promote continuous improvement

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor's Degree Life sciences or related field with 15 years clinical research experience including 10 years of project management experience
• Proven people management skills. Ability to manage a global team of Project Leaders (20+) to deliver results as well as mentoring, training and coaching
• Strong leadership competencies and viewed as a leading expert within the field by peers
• Extensive knowledge of multiple job areas obtained through advanced education and experience
• Solid knowledge of clinical trials: broad protocol knowledge, therapeutic knowledge, clinical trial conduct, understanding of the competitive environment and how to communicate/demonstrate value

go to method of application »

The role includes being part of the core project team responsible for clinical delivery and oversight of complex, global full service, multi-regional studies or a program of studies to meet contractual requirements and in accordance with SOPs, policies and practices. You will leverage therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers and focus on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction.

• Contribute to the development of the project delivery strategy for RFPs. Participate in bid defense preparations. Lead bid defense presentations in partnership with business development for large, complex, multi-service, multi-region studies or programs. Understand project strategy and operationalise the agreed upon approach.
• Oversee the development of integrated study management plans with the core project team
• Oversee the execution of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures
• Recognize systemic issues at the program or portfolio level and identify solutions with the project teams, recommend actions to improve efficiencies and oversee the implementation of best practices, address escalation items with the customer
• Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles
• Oversee progress against contract and prepare/present project information proactively to all stakeholders internally and externally
• Responsible for the oversight and team management of large and complex studies or programs of studies
• Responsible for portfolio management with one customer or therapeutic area
• Manage strategic risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans
• Drive consistency of operational delivery across customer’s projects/programs/portfolio
• Build the cross-functional program/portfolio team and lead their efforts
• Responsible for ensuring the financial success of programs/portfolio
• Forecast and identify opportunities to accelerate activities to bring revenue forward
• Identify and communicate strategic lessons learned and best practices to promote continuous improvement

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor's Degree Life sciences or related field with 15 years clinical research experience including 10 years of project management experience
• Proven people management skills. Ability to manage a global team of Project Leaders (20+) to deliver results as well as mentoring, training and coaching
• Strong leadership competencies and viewed as a leading expert within the field by peers
• Extensive knowledge of multiple job areas obtained through advanced education and experience
• Solid knowledge of clinical trials: broad protocol knowledge, therapeutic knowledge, clinical trial conduct, understanding of the competitive environment and how to communicate/demonstrate value

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JOB DESCRIPTION

• Developing and maintaining multiple stakeholder relationships within each account, and by leveraging IQVIA’s solutions to add value and identify new business opportunities and ultimately grow revenue.

Essential Functions

• Actively prospect and leverage potential new business opportunities within specified potential new and/or existing customers.
• Actively network in the MedTech industry to establish relationships and to identify potential opportunities.
• Establish and execute a comprehensive sales plan for each target account, ensuring the appropriate strategy/solution is proposed to customer and results are monitored.
• Lead the sales process and leverage regional and global subject-matter experts as required.
• Coordinate with various internal stakeholders to develop/ensure the development of proposals, and handle follow-up related to the sale and drive completion of contractual documents.
• Effectively establishes and grows business-critical relationships with multiple stakeholders (typically business intelligence, marketing, sales management at a senior to executive level) within assigned accounts.
• Develops and maintains a comprehensive body of knowledge of the the client's business evolution, portfolio, policies, markets, financial performance, buying processes and overall operational dynamics.
• Understands the key current and future priorites of the client to achieve or exceed the assigned revenue and growth goals in assigned accounts.
• Based on long-term partnership with client, acts as a knowledgeable advisor on marketing, market research, sales management, industry issues, trends and IQVIA product, consulting and service capabilities.
• Anticipates clients’ needs and, in collaboration with IQVIA consulting and other enabling departments, develops and presents proposed solutions to client's complex business issues.
• Identifies and leads the pursuit of the targeted new business and contract expansion opportunities within assigned accounts.
• Represents the company to the client and the client to the company in all sales related activities.
• Monitors client satisfaction with all deliverables and works with Consulting, the Client Service Management, Query Resolution Management and other enabling departments to achieve and maintain a high level of customer satisfaction.
• Effectively manages all contract subscription, renewals and all negotiations (based on a proactive contract strategy) to maintain sustainable account partnerships. 
• Proactively works with global and regional account management in the pursuit of multi-country opportunities.
• Remains sensitive to IQVIA’s competitors’ activities and suggests counter strategies.
• Monitors, analyzes and reports on business (assigned accounts) performances.
• Accurately manages internal CRM requirements and provides weekly input on committed, and potential opportunities.

Minimum Required Education and Experience

• Typically requires 5+ years of prior relevant MedTech industry experience, ideally in multiple roles such as Sales (required), Account Management (preferred), Business Development (preferred), Marketing (preferred) and Business Operations/Analytics (preferred). 
• Bachelor's Degree required, Master's degree advantageous.

Skills and Abilities

Industry knowledge    

• Understanding of the nuances of the South African MedTech and healthcare sector

Emotional intelligence    

• Connect with and effectively manage all client and internal engagements

Problem solving and analytical    

• Basic analytical ability to assess challenges and provide solutions

Collaborative  

•  Works well with others to proactively meet client needs and drive success

Action and deadline orientated  

•  Operates with a sense of urgency in a deadline-orientated environment

Learnability    

• Strong ability to expand their knowledge base and continuously grow

Attention to detail    

• Detail-orientated, but not at the cost of slowing down progress

Strong communicator  

•  Articulate an ability to effectively express themselves

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Job Overview

• Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines within our sponsor dedicated FSP division. Candidate will assist with initial study start up activities followed by traditional monitoring in full CRA capacity.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications

• Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
• 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Good negotiating and communication skills with ability to challenge, if applicable.
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

go to method of application »

Job Overview

• Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines within our sponsor dedicated FSP division. Candidate will assist with initial study start up activities followed by traditional monitoring in full CRA capacity.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications

• Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
• 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Good negotiating and communication skills with ability to challenge, if applicable.
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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Job Overview

• Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions

• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
• Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
• Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
• Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
• Mentor and coach colleagues as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May take a lead role in developing long standing relationships with preferred IQVIA customers.
• Deliver presentations/training to clients, colleagues and professional bodies, as required.
• May be involved in activities related to monthly study budget planning and reviews.

Qualifications

• Bachelor's Degree Life sciences or related field
• 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
• Strong negotiation and communication skills with ability to challenge
• Excellent interpersonal skills and strong team player
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
• Demonstrated proficiency in using systems and technology to achieve work objectives
• Good regulatory and/or technical writing skills
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good presentation skills
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Excellent understanding of study financial management
• Proven ability to work on multiple projects balancing competing priorities

go to method of application »

Job Overview

• Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions

• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
• Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
• Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
• Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May take a lead role in developing long standing relationships with preferred IQVIA customers.
• Deliver presentations/training to clients, colleagues and professional bodies, as required.
• May be involved in activities related to monthly study budget planning and reviews.

Qualifications

• Bachelor's Degree Life sciences or related field 
• 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
• Strong negotiation and communication skills with ability to challenge
• Excellent interpersonal skills and strong team player
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
• Demonstrated proficiency in using systems and technology to achieve work objectives
• Good regulatory and/or technical writing skills
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good presentation skills
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Excellent understanding of study financial management
• Proven ability to work on multiple projects balancing competing priorities

go to method of application »

Job Overview

• Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions

• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
• Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
• Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
• Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May take a lead role in developing long standing relationships with preferred IQVIA customers.
• Deliver presentations/training to clients, colleagues and professional bodies, as required.
• May be involved in activities related to monthly study budget planning and reviews.

Qualifications

• Bachelor's Degree Life sciences or related field 
• 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
• Strong negotiation and communication skills with ability to challenge
• Excellent interpersonal skills and strong team player
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
• Demonstrated proficiency in using systems and technology to achieve work objectives
• Good regulatory and/or technical writing skills
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good presentation skills
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Excellent understanding of study financial management
• Proven ability to work on multiple projects balancing competing priorities

go to method of application »

Job Overview

• Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers

Essential Functions

• Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• May be responsible for delivery and management of smaller, less complex, regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• Provide input to line managers of their project team members’ performance relative to project tasks.
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;

Qualifications

• Bachelor's Degree Life sciences or related field Req
• Requires greater than 5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience.
• Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.;
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
• Problem solving - Strong problem solving skills.
• Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
• Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Organisation - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Prioritisation - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• Quality - Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
• IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

go to method of application »

Job Overview

• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Degree in scientific discipline or health care preferred.
• Requires at least 3+ years of of on-site independent monitoring experience..
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

go to method of application »

The role

• The ontology and Knowledge Graph AI expert will be responsible for the development of novel effective products that can capitalise on ontologies, data and technology integration to advance the state of the art of semantic interoperability within IQVIA and across the industry, through direct and indirect engagement with our customers.
• The role will interface with multiple teams within the company, including, but not limited to: NLP, ETL, Data Science, Graph Analytics, Data Governance, Engineering.

In this senior key role, you will be expected to:

• Support client development and including ontologies as part of broader proposals and solution architecture
• Be the recognised expert and go-to person for applications of AI and ML to medical ontologies and KGs.
• Collaborate with teams across the company to develop and implement novel approaches to support ontology mapping and maintenance.
• Supervise operational resources implementing ontology-based platforms.
• Create value (internally and to customers) via the application of advanced methodologies for knowledge engineering.
• Engage across the whole data solution life cycle, from engagement to execution and delivery.
• Contribute to the definition and execution of the ontology and KG strategy in IQVIA.

Your profile

• You are a subject matter expert in ontologies and AI with a will to drive innovation and make an impact in the real world. You are curious and strive to keep abreast of most current developments and you can combine depth of knowledge with pragmatism in execution.
• You are comfortable working as an individual contributor, team player or supervisor. A good communicator, you thrive in a fast-paced collaborative, distributed, multi-cultural, and dynamic environment.

Requirements:

Must Have

• An advanced degree in Computer Science, medical informatics, or related subject with significant professional experience
• Experienced in at least one of the following: link prediction, ontology matching, ontology repair, graph embeddings.
• Working experience in some of: Data Management, Information and Data Strategy, Data Office Organization, Data Governance, Architecture & Semantics, Ontology Design, Master Data Management and Metadata Management
• Demonstrated experience in developing technical solutions based on ontologies
• Demonstrated experience in building ontologies and/or knowledge graphs
• Proficient with ontology related languages (e.g.: OWL, RDF) and technologies (e.g.: Protégé, Jena).
• Ability to collaborate cross-functionally with internal teams, and/or experience in consulting
• Experience in Big Data ETL projects: knowledge of the process and data flow from the ETL, curation, enrichment, etc.
• Generalist knowledge of NLP and ML with deep expertise in some area of competence
• Eagerness to learn more and stay up to date with industry best practices
• Proficiency in English

Preferred

• Experience in the healthcare and life sciences data ecosystem
• Knowledge of healthcare data standards and ontologies (e.g.: HL7, FHIR, DICOM, OpenEHR, OMOP, i2b2, ISO13606, ICD-10, LOINC, SNOMED-CT, GO, HPO, etc.)
• Experience with graph databases, triple stores, and graph query languages (e. g. Neo4J, Stardog, Cypher, SPARQL, Gremlin).
• Hands on experience with NLP, Data Mining, Knowledge Engineering (entity recognition and linking).
• Good knowledge of software, application design and architecture best practices
• Knowledge of modern data architectures and engineering principles, including Data Lakes, Data Hubs, Big Data Engineering, ETL / Data Integration, Data Streams/Event Driven Architecture, Business Intelligence and Advanced Analytics on various platforms and technology stacks – RDBMS, NoSQL, Graph - On-Prem, Hybrid and Cloud (Azure), DevOps, Serverless.

Nice-to have

• Experience on public tenders & commercial proposals development
• Experience in change management, awareness, training
• Experience with managing cross-functional projects

go to method of application »

Job Overview

• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred.
• Requires at least 2 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

go to method of application »

JOB OVERVIEW

• IQVIA Biotech is currently looking for a Manager with a proven experience in Clinical Data Management, that will lead and support a team of Data Management professionals to efficiently produce databases that meet customer requirements.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manage a team of professional Data Management staff.
• Size of team could vary from 5+ upwards -15, depending on the Data Management Function.
• Define and prioritize resource requirements and manage resource assignments across projects.
• Directly responsible for utilization of staff.
• Assess and document competency of staff to satisfy position responsibilities.
• Regularly set goals and evaluates and documents performance.
• Propose salaries, promotion and termination actions.
• Actively contribute to recruitment of new staff.
• Implementation of department/office objectives.
• Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers.
• Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency.
• Participate in the development and implementation of new processes and technology.
• Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.
• Identify and address professional development/training needs of staff.
• Mentor staff members to develop Data Management process, system, and drug development expertise.
• Provide operational input into proposals and scope of work.
• Participate in proposal defenses.
• Attend customer meetings and lead discussions of project requirements and strategic planning.
• Understand scope of work, budget, and scope assumptions.
• Identify out-of-scope work and provide revised costs with supporting documentation.
• Ensure project milestones are met according to agreed upon timelines.
• Actively manage quality throughout project.
• May be Project Manager/Project Lead for a major study or a series/group of studies.
• Manage staff in accordance with organization’s policies and applicable regulations.
• Responsibilities include planning, assigning, and directing work appraising performance and guiding professional development rewarding and disciplining employees addressing employee relations issues and resolving problems.
• Approve actions on human resources matters.

QUALIFICATIONS:

• Bachelor's Degree Clinical, biological or mathematical sciences or related field
• 7 years of relevant work experience including people management. Equivalent combination of education, training and experience.
• Advanced knowledge of Data Management processes and systems.
• Solid understanding of clinical drug development process.
• Excellent written and oral communication skills. Proven leadership skills.
• Excellent organizational skills and demonstrated ability to manage projects.
• Effective problem solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Advanced knowledge of Data Management processes and systems.
• Solid understanding of clinical drug development process.
• Excellent written and oral communication skills.
• Proven leadership skills.
• Excellent organizational skills and demonstrated ability to manage projects. Effective problem solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

go to method of application »

JOB OVERVIEW

• IQVIA Biotech is currently looking for a Manager with a proven experience in Clinical Data Management, that will lead and support a team of Data Management professionals to efficiently produce databases that meet customer requirements.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manage a team of professional Data Management staff.
• Size of team could vary from 5+ upwards -15, depending on the Data Management Function.
• Define and prioritize resource requirements and manage resource assignments across projects.
• Directly responsible for utilization of staff.
• Assess and document competency of staff to satisfy position responsibilities.
• Regularly set goals and evaluates and documents performance.
• Propose salaries, promotion and termination actions.
• Actively contribute to recruitment of new staff.
• Implementation of department/office objectives.
• Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers.
• Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency.
• Participate in the development and implementation of new processes and technology.
• Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.
• Identify and address professional development/training needs of staff.
• Mentor staff members to develop Data Management process, system, and drug development expertise.
• Provide operational input into proposals and scope of work.
• Participate in proposal defenses.
• Attend customer meetings and lead discussions of project requirements and strategic planning.
• Understand scope of work, budget, and scope assumptions.
• Identify out-of-scope work and provide revised costs with supporting documentation.
• Ensure project milestones are met according to agreed upon timelines.
• Actively manage quality throughout project.
• May be Project Manager/Project Lead for a major study or a series/group of studies.
• Manage staff in accordance with organization’s policies and applicable regulations.
• Responsibilities include planning, assigning, and directing work appraising performance and guiding professional development rewarding and disciplining employees addressing employee relations issues and resolving problems.
• Approve actions on human resources matters.

QUALIFICATIONS:

• Bachelor's Degree Clinical, biological or mathematical sciences or related field
• 7 years of relevant work experience including people management. Equivalent combination of education, training and experience.
• Advanced knowledge of Data Management processes and systems.
• Solid understanding of clinical drug development process.
• Excellent written and oral communication skills. Proven leadership skills.
• Excellent organizational skills and demonstrated ability to manage projects.
• Effective problem solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Advanced knowledge of Data Management processes and systems.
• Solid understanding of clinical drug development process.
• Excellent written and oral communication skills.
• Proven leadership skills.
• Excellent organizational skills and demonstrated ability to manage projects. Effective problem solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

go to method of application »

JOB OVERVIEW

• IQVIA Biotech is currently looking for a Manager with a proven experience in Clinical Data Management, that will lead and support a team of Data Management professionals to efficiently produce databases that meet customer requirements.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manage a team of professional Data Management staff.
• Size of team could vary from 5+ upwards -15, depending on the Data Management Function.
• Define and prioritize resource requirements and manage resource assignments across projects.
• Directly responsible for utilization of staff.
• Assess and document competency of staff to satisfy position responsibilities.
• Regularly set goals and evaluates and documents performance.
• Propose salaries, promotion and termination actions.
• Actively contribute to recruitment of new staff.
• Implementation of department/office objectives.
• Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers.
• Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency.
• Participate in the development and implementation of new processes and technology.
• Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.
• Identify and address professional development/training needs of staff.
• Mentor staff members to develop Data Management process, system, and drug development expertise.
• Provide operational input into proposals and scope of work.
• Participate in proposal defenses.
• Attend customer meetings and lead discussions of project requirements and strategic planning.
• Understand scope of work, budget, and scope assumptions.
• Identify out-of-scope work and provide revised costs with supporting documentation.
• Ensure project milestones are met according to agreed upon timelines.
• Actively manage quality throughout project.
• May be Project Manager/Project Lead for a major study or a series/group of studies.
• Manage staff in accordance with organization’s policies and applicable regulations.
• Responsibilities include planning, assigning, and directing work appraising performance and guiding professional development rewarding and disciplining employees addressing employee relations issues and resolving problems.
• Approve actions on human resources matters.

QUALIFICATIONS:

• Bachelor's Degree Clinical, biological or mathematical sciences or related field
• 7 years of relevant work experience including people management. Equivalent combination of education, training and experience.
• Advanced knowledge of Data Management processes and systems.
• Solid understanding of clinical drug development process.
• Excellent written and oral communication skills. Proven leadership skills.
• Excellent organizational skills and demonstrated ability to manage projects.
• Effective problem solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Advanced knowledge of Data Management processes and systems.
• Solid understanding of clinical drug development process.
• Excellent written and oral communication skills.
• Proven leadership skills.
• Excellent organizational skills and demonstrated ability to manage projects. Effective problem solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

go to method of application »

• As the Local Qualified Person (QP) for Pharmacovigilance you will act as local Qualified Person for customers requiring the services for their product.

RESPONSIBILITIES

• Act as the local Qualified Person in accordance with requirements set out in IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
• Availability on a 24/7 basis to receive calls from the local Competent Authority as required. Act as the contact point for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors during statutory inspections.
• Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal l products.
• Verifies that his/her name and contact details have been notified to the Competent Authority upon contract commencement.
• Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
• Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.
• Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns.
• Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent.
•  Around 4 years relevant clinical experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.
•  Resident in South Africa with fluent Afrikaans language skills (at least C2).
•  Excellent command of the English language.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• In-depth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
• Excellent knowledge of the pharmacovigilance legal framework in the EU and in South Africa.
• Solid knowledge of relevant Standard Operating Procedures (SOPs).
• Possess excellent written and verbal communication skills.
• Excellent analytical and problem-solving approach when interpreting safety reports, literature and undergoing inspections.
• Strong organizational and project management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, customers and third parties
• Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
• Demonstrate an understanding of compliance and of quality management systems

PHYSICAL REQUIREMENTS

• Availability by phone 24/7 for Competent Authority enquiries
• Resident in South Africa
• May require occasional travel