Job Vacancies at IQVIA

ESSENTIAL FUNCTIONS

• Provide input in to the development of integrated study management plans with the core project team and/or sub-team.
• Accountable for assigned portion 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.
• Set objectives of project 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 internal stakeholders. Support the project leader to prepare/present project and/or sub-team information proactively to external stakeholders.
• Identify risk (positive and negative) and contingencies and partner with project leader in problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project sub-team members and partner with project leader planning/implementing appropriate corrective and preventative action plans.
• May serve as primary (for small projects) or back-up project contact with customer.
• Lead the efforts of a project sub-team, responsible for managing cross-collaboration of the sub-team to support milestone achievement and to manage issues and obstacles.
• Support the project leader in ensuring the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward in partnership with the senior project leader.
• Identify changes in scope and partner with project leader to 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

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor's degree in life sciences or related field
• Global project management experience within the drug development industry, with previous CRO experience is ideal.
• Minimum 2 years’ experience in clinical trials; or equivalent combination of education, training and experience
• In depth therapeutic knowledge in one or more of the following area’s: Neurology (e.g. MS, stroke, epilepsy), Neuro-Degenerative Diseases (e.g. Alzheimer’s, Parkinson, ALS), Psychiatry (e.g. schizophrenia, bipolar, MDD, sexual dysfunction, sleep disorders), Pain and Rare Diseases (e.g. Duchenne’s, NMO) would be an advantage

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As part of your role, you will

• Review Requests for Proposal (RFP). Identify information for proposal text and budget development and work closely with proposal development team to prepare and finalize proposals.  
• Drive the execution of the Proposal throughout the lifecycle of the opportunity developing a strategic deliverable in accordance with proposals prioritization. 
• Provide support and assistance to other Proposal Developers in the delivery of assigned opportunities.  
• Lead and participate in global strategy calls to discuss customer requirements and identify discrepancies in customer information.
• Perform quality reviews of own work, processes and tasks to eliminate errors or defects. 
• Update and maintain corporate databases as required and ensure accurate information is included in tracking reports.  
• Proactively build internal and external customer relationships, working together to add value and improve the proposals and award processes. 
• Identify key challenges and ultimate selling points from Request for Proposal (RFP) documentation.  
• Engage with internal stakeholders to promote effective and streamlined budgeting strategies during proposal and post award stages. 
• Act as the primary GBO interface with internal and external customers to develop the new award preliminary contracts. 
• Develop and implement execution plans for all new award preliminary contracts to ensure timely execution.  
• Review master service agreements (MSAs), ensuring all contractual language is current, and inclusive of any new “standard” terms. 
• Actively participate when attending customer meetings to represent the department. 
• Perform all other duties as assigned. 

You are

• Analytical thinker with excellent verbal and written communication skills.
• Incredibly passionate about what you do.
• Striving to deliver excellence.
• Possess a quality mindset, showing a concern for quality in all areas.
• Able to prioritize, organize and drive execution of multiple deliverables.
• Able to adapt and to manage change effectively.
• Able to establish and maintain effective working relationships with your internal and external stakeholders.

To excel in this role

• You will have strong working experience with Microsoft Word and Excel and have a good understanding of costing models.
• You will have a Degree in Life Science, Business Management, Finance, Legal or related field.
• You will have a strong interest in proposals and contract writing
• Ideally you will have a knowledge of the Clinical Research industry. 

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Main responsibilities

• Provide leadership and vision to the team
• Manage and deliver several large scale, high complexity/non-standard aspect studies across a range of sponsors and Therapeutic areas
• Manage sponsors at both Study and Programme Level
• Manage delivery of areas requiring specific expertise (e.g Process, Finance)
• Ensure milestones meet timelines and quality deliverables
• Provide project management expertise working with customer data managers, key decision makers and internal team members to manage continuous process improvements and provide technical expertise
• Ensure open communications with customer and Quintiles management to manage and meet contractual obligations
• Provide input for and perform direct negotiations with customer
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
• Support DM service delivery with comprehensive DM process and technical expertise in executing projects
• Create and/or review and sign-off on all data management plan (DMP) documents
• Track service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
• Maintain internal tracking databases and systems

Minimum Education & Experience

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• Around 5 years direct Data Management experience, including 3 or more years as a Clinical Data Management project lead is preferred
• Ability to maintain strong customer relationships

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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:

• Bachelor's degree in life sciences or related field
• Global project management experience within the drug development industry, with previous CRO experience is ideal.
• Minimum 4 years prior project management experience and experience in clinical operations; or equivalent combination of education, training and experience
• In-depth therapeutic knowledge in one of our Dermatology therapeutic area

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JOB DESCRIPTION

As a Clinical Project Manager you will manage cross functional teams and liaise directly between IQVIA Biotech functions and the customer, acting as that accountable point for delivery and quality whilst maintaining financial control. You will be supported by domain experts in every function, enabled by best-in-class technology and data analytics. 

• Key collaborators are the Clinical Lead for site management, the Project Vendor Manager, the Project Management Analyst for project coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up. 
• This is an important and high-profile role within our Research & Development Operation and IQVIA’ Biotech´s size and global footprint will present you with the breadth of opportunities necessary to develop your career.

Typically assigned to one or two projects, or a program, responsibilities might include:

• Leading global cross-functional project team delivery, accountable for achievement of milestones and quality of contracted scope
• Serving as the primary contact with the customer for progress and governance
• Developing study management plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures
• Anticipating risk and implementing mitigation strategies
• Managing study team assignments, accountability and resource requirements 
• Ensuring the study budget is managed proactively including scope changes and financial systems are accurate

Experience Required:

• Bachelor's degree in life sciences or related field 
• Global project management experience within the drug development industry, with previous CRO experience is a must. 
• Minimum 2-4 years prior project management experienceand experience in clinical operations; or equivalent combination of education, training and experience
• In depth therapeutic knowledge of Internal Medicine

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JOB DESCRIPTION

As a Clinical Project Manager you will manage cross functional teams and liaise directly between IQVIA Biotech functions and the customer, acting as that accountable point for delivery and quality whilst maintaining financial control. You will be supported by domain experts in every function, enabled by best-in-class technology and data analytics. 

• Key collaborators are the Clinical Lead for site management, the Project Vendor Manager, the Project Management Analyst for project coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up. 
• This is an important and high-profile role within our Research & Development Operation and IQVIA’ Biotech´s size and global footprint will present you with the breadth of opportunities necessary to develop your career.
• Typically assigned to one or two projects, or a program, responsibilities might include:
• Leading global cross-functional project team delivery, accountable for achievement of milestones and quality of contracted scope
• Serving as the primary contact with the customer for progress and governance
• Developing study management plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures
• Anticipating risk and implementing mitigation strategies
• Managing study team assignments, accountability and resource requirements 
• Ensuring the study budget is managed proactively including scope changes and financial systems are accurate

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor's degree in life sciences or related field 
• Global project management experience within the drug development industry, with previous CRO experience is a must. 
• Minimum 2-4 years prior project management experienceand experience in clinical operations; or equivalent combination of education, training and experience
• In depth therapeutic knowledge in Cell and Gene Therapies, First in Human and Paediatric Oncology

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JOB DESCRIPTION

Roles and Responsibilities

A lead is expected to contribute to the firm's growth and development in a variety of ways, including:

• Project Delivery: Understand client requirements, project scope and deliverables; Lead project delivery and client meetings under overall guidance of EM/ Senior management; follow Assess-Design-Develop-Deliver-Monitor process in various work modules of the project; project team management and coordination with internal and external stakeholders etc. Also, would manage vendor, Design & Delivery and Data Processing, maintain field schedules, monitoring and communicating deadlines to team; checking programmed questionnaires; monitoring and maintaining progress of fieldwork; specifying deliverable requirements; final review of member deliverables. Contribute to team process improvements
• Operational excellence: Ensuring project profitability, timely delivery of projects, invoicing and collection, quality & risk management, positive feedbacks from the client, etc.
• Business Development: Identification and development of work opportunities, client requirement analysis, development of EoI/proposals, client presentations, etc.
• Practice Development: Support and lead learning and development initiatives for the team/project/organization.
• Thought Leadership: Manage research, analysis and delivery of thought leadership reports (global and domestic) with guidance from senior team professionals
• As lead, the primary role would be to manage & lead project work streams/modules and client interactions with support from Sr. consultants/ Consultants in team. Additionally, you would be coaching team on technical and management areas.

Eligibility criteria and requirements:

• Master’s in Public Health / Health Administration / Social Sciences / Business Administration/ Economics/ Public Policy / international development,
• Graduation: Any (MBBS/BHMS is desirable)
• Should have relevant experience of 10+ years working for a governmental, intergovernmental and/or non-governmental organization in health sector
• Should have a flair for business development through proposal / grant writing and proactive outreach to the potential funders. Should be comfortable in making an elevator pitch to external stakeholders. Should be able to own and chase revenue and sales target numbers.
• Prior consulting / advisory experience in public health sector in Africa is a desirable
• Excellent understanding of health sector, public health structure, multi-laterals and health programs in Africa. Experience in one or more areas such as Maternal and Child Health, TB, Malaria, Non-Communicable Diseases, Healthcare Research, etc.
• Prior experience of proposal development and managing projects for government clients and donor agencies
• Excellent project management skills with effective communication and team-management skills
• Government and development partner Stakeholder management, financial planning and management, team coordination and good writing skills.
• Project management and Problem-solving capabilities
• Report writing and PowerPoint development skills
• Willingness to travel and adaptability to change
• Stay informed about research and trends in our program areas and in research and evaluation to inform our strategy accordingly.
• Network with other institutions running similar programs to find areas of collaboration and knowledge sharing
• Experience with Africa CDC, Africa Union, UN agencies, The Global Fund, etc would be an asset

Eligibility criteria and requirements:

Language competency

• English: minimum C1 level
• French: minimum C1 level
• Portuguese: B2 level or more would be a considerable advantage

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Job Qualifications

• Bachelor's Degree Req computer science or any related field.
• Five (5) years work experience in similar role.
• Demonstrated ability to understand client requirements, systems and processes.

Intermediate to Senior experience in ETL using SSIS

• Knowledge of businesswide organization and IQVIA systems and best practices.
• Indepth knowledge of current systems and business processes.
• High communication skills.
• Capability to work in multicultural team environment.
• C# knowledge is a bonus
• Power BI & QlikView knowledge are a plus.

Job Roles and Responsibilities:

• BI Project Management – liaising with Centrix and CCP’s clients regarding the various project requirements and timelines. Analyze the clients business and Business Intelligence needs and formulate a structured plan based on different Complexities and Variables.
• Manage CCP and Centrix QlikView environment, including but not limited to model delivery of CCP and Centrix QlikView Formulary Management models, Adhoc CCP and Centrix QlikView developed.
• Quality Assurance – All models developed are subject to stringent QA process as per CCP development policy and best practice. Provided QA services for CCP’s internal development.
• Install, upgrade and administer QlikView software including QlikView Server, Publisher, Desktop and NPrinting.
• Adhoc Development –Adhoc model development that were not project related, mostly relating to improving efficiencies within the business and once off client requests.
• Establish positive relationships with customers.
• Identify customer needs and work cohesively to make sure these needs are met.
• Integrate 3rd party software such as GeoQlik into QlikView applications.
• Provides necessary required QlikView design and developer capabilities to maintain our QlikView Solutions Partner Status lose potential QlikView and Qlik Sense sales and implementations.

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Essential Functions Regulatory Role

• Act as a Regional Regulatory affairs lead and strategist on complex regulatory projects, who is able to create and follow through project strategy on country level in Saudi and /or South Africa region
• Act as client’ representative in front of health authorities SAHPRA and/or SFDA and with t client partner (Agents/distributes) in several countries. 
• Scope of countries for the role based in south Africa is: South Africa, Namibia and Botswana
• Scope of countries for the role based in Saudi is: Saudi Arabia and GHC mainly. Gulf experience is a plus. (Kuwait, Bahrain, Oman, Qatar, UAE)
• Prepare, review and submit regulatory documentation (for example: CTD/eCTD submissions), as appropriate; follow through post approval commitments.
• Meet with Officials in Health authorities were applicable and represent the client.
• Establish strong relationships with stakeholders; present regulatory projects and progress, discuss issues and customer comments.
• Act as a Subject matter expert implementing Regulatory knowledge for post marketing approvals and well-established marketed products in Medical device, pharmaceutical and Biological innovative products in, Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing/ Complex cross country change assessments/Market authorization approvals/ Gap analysis and assessments safety variations and manufacturing site renewals or as applicable.
• Up to date with regulatory intelligence information in different health authorities, communicating to clients and working groups to define best strategy and anticipate future trends.
• Update client regulatory compliance systems and ensure following the metrics and SOPs
• Support pricing reg-intal in the country and provide advice as needed, prepare pricing submission packages as required and based on client request and variation requirements.
• Understands the Scope of Work, deliverables and management of budget for several given projects and manages workload as appropriate.
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training/ development/on-boarding
• May present to clients on complex regulatory processes at large full-service bid defense meetings; and preparation for new opportunities.
• Network with clinical operation, IMS and business development and other cross-functional teams in additional to maximize external networking with potential clients and stakeholders to identify potential opportunity and bring more business.
• May act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
• Performs other tasks or assignments, as delegated by Regulatory management.
• Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement as needed.
• May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific improvement initiatives.
• Upon agreement with the Line Manager: Perform any other reasonable tasks as required by the role. ;

Qualifications

• Degree in pharmaceutical science is a must. Professional post graduate degree is a plus
• High English proficiency, French proficiency is a plus
• for the senior specialist role: At least 3-5 years relevant experience in regulatory national and/or regional scope of work in saudi and/or GCC. (For Saudi role). South Africa and west African countries for the South Africa role
• for the Manager role: At least 5-7 years relevant experience in regulatory national and/or regional scope of work in Saudi and/or GCC. (For Saudi role). South Africa and west African countries for the South Africa role
• Good understanding of the regulations and related guidelines in Saudi/gulf and (or) north /west Africa region
• Good understanding of Regulations (Pharmaceutical and Biological is a must).Medical device is a plus
• This is for both generic and innovative medicine
• Good knowledge of different regulatory dossiers : CTD, e-CTD, NeeS, ..is a must.
• Capacity to read and understand high level SOPs, e-trainings, work easily on veeva and collaborate according to ways of work
• Possesses a specific regulatory and technical expertise;
• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good manufacturing Practice (GMP), applicable regulatory requirements,. Knowledge of National Regulations and (CMC).
• Knowledge of Pharmaceutical industry operations, the link of change controls to production and supply and SKU sharing
• Good, solid interpersonal communication and organization skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office (power BI, Onenote, SharePoint, planner, Word, Excel, Teams, Visio), publishing applications and tools, as applicable;
• Strong software knowledge of finance and planning systems (oracle, SAP, …). Strong knowledge of Veeva vault
• Demonstrates self-motivation and enthusiasm, high sense of ownership

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Job duties:

• Development of study outputs including SDTM/ADaM datasets, tables, listings, figures and QC of requested output.
• Participate in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.
• Interact with internal departments of the sponsor - Biostatistics, Data Management, Regulatory Operations and Medical Writing.
• Collaborates with peers and statisticians to ensure the submission readiness of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
• Involvement with creation and maintaining programming specifications for SDTM, ADaM and integration of data in support of ISS/ISE.
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
• Perform additional statistical analyses including but not limited to: support responses to regulatory agencies; generate integrated summary of safety and efficacy; support publications and presentations; support planning and reporting of clinical trials via exploratory analyses of available data; replicate vendor and statistician analyses for QC.

Our expectations of you:

• 5 years or more in SAS programming for clinical trial data.
• Bachelor’s degree in Math, Stats, Computer Science, Pharmacy, Biology or related.
• Strong knowledge in CDISC standards (SDTM, ADaM).
• Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG.
• Knowledge of pharmaceutical clinical development - understanding of safety deliverables and efficacy analysis supporting regulatory submissions.
• Knowledge of base SAS, proc report, exposure to macros, current CDISC data structures, and standardization methodology; demonstrated ability to debug SAS programs.
• High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF.
• Demonstrated teamwork, pride of ownership, accountability, problem-solving and innovative skills.

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Essential Functions

• Participates or leads teams in the design, development and delivery of consulting projects or components of larger, complex projects.
• Reviews and analyzes client requirements or problems and assists in the development of proposals of cost effective solutions that ensure profitability and high client satisfaction.
• Provides direction and guidance to Analysts, Consultants, and where relevant, to Statistical Services assigned to engagement.
• Develops detailed documentation and specifications.
• Performs qualitative and/or quantitative analyses to assist in the identification of client issues and the development of client specific solutions.
• Designs, structures and delivers client reports and presentations that are appropriate to the characteristics or needs of the audience.
• May deliver some findings to clients.
• Recommends improvements and alternative solutions to resolve problems.
• May identify new business opportunities of follow-on work and new leads at assigned client.
• Provides follow-up with client after project deliverable has been completed to ensure client satisfaction.
• Proactively develops broader and deeper knowledge of related consulting methodologies and life sciences market through on the job experience and participation in training opportunities. Begins to develop CoE specific subject matter expertise.
• When acting as Project Manager, proactively manages project timelines and manages day to day communication with the client and team members.

Qualifications

• Bachelor's Degree in Economics, Business Administration or any related field.
• Master's Degree in Business Administration Preferable.
• Minimum 5-8 years of related experience in consulting and/or life sciences industry.
• Possesses solid project management skills and client influencing and relationship building skills.
• Works willingly and effectively with others in and across the organization to accomplish team goals.
• Experienced with developing consultative relationships with senior level managers and executives at clients in the life science industry.
• Ability to manage multiple projects, juggle priorities and deliver on tight deadlines.
• Knowledge of consulting methodologies, tools and techniques related to functional area.
• Knowledge of key issues and current developments in the life science industry.
• Excellent presentation, communication and client influencing skills.
• Has established network and referral contacts.
• Has necessary subject matter expertise to effectively manage projects within a given CoE.

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Essential Functions

• Manage the day-to-day contract, proposal and other designated processes for large complex contracts.
• Act as regional expert on contracts, proposals and / or other designated processes and key interface for assigned customers, ensuring consistency in approach, metrics and format.
• Manage project requirements, identify discrepancies and interact with customers to resolve issues.
• Develop and implement processes with a primary focus on increasing customer satisfaction and by creating efficiencies while maintaining consistency among all teams.
• Provide direction and strategy on projects and initiatives with minimal oversight.
• Maintain a focus and actively work towards attainment of all corporate goals (including but not limited to revenue, sales, and employee retention) and implement strategies to achieve those goals.
• Support with development and negotiation of MSA.
• Develop in depth understanding of, and be compliant to all processes and policies relating to the development of contracts and proposals.
• Act as primary internal customer interface, responsible for developing key relationships.
• May participate in bid defense, customer meetings and on task forces as required.
• Provide advice, support and guidance as needed and serve as a mentor to colleagues.
• Perform other duties as assigned.

Qualifications

• Bachelor's Degree in Life Science, Business Management or related field and 7 years experience in Contracts or Proposals or equivalent combination of education, training, and experience.; Req
• Knowledge of CRO Industry.
• Excellent knowledge of Microsoft Excel, Word and understanding of costing models.
• Excellent knowledge of contract, proposals and budget processes and ability to interpret budgets and protocols.
• Possess strong analytical skills and excellent verbal and written communication skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.

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Job Overview

Coordinate and manage the contracts, proposals and other designated processes for assigned customers to efficiently produce accurate and timely information.;

Essential Functions

• Manage the day-to-day contract, proposal and other designated processes for large complex contracts.
• Act as regional expert on contracts, proposals and / or other designated processes and key interface for assigned customers, ensuring consistency in approach, metrics and format.
• Manage project requirements, identify discrepancies and interact with customers to resolve issues.
• Develop and implement processes with a primary focus on increasing customer satisfaction and by creating efficiencies while maintaining consistency among all teams.
• Provide direction and strategy on projects and initiatives with minimal oversight.
• Maintain a focus and actively work towards attainment of all corporate goals (including but not limited to revenue, sales, and employee retention) and implement strategies to achieve those goals.
• Support with develpment and negotiation of MSA.
• Develop in depth understanding of, and be compliant to all processes and policies relating to the development of contracts and proposals.
• Act as primary internal customer interface, responsible for developing key relationships.
• May participate in bid defense, customer meetings and on task forces as required.
• Provide advice, support and guidance as needed and serve as a mentor to colleagues.
• Perform other duties as assigned.

Qualifications

• Bachelor's Degree in Life Science, Business Management or related field and 7 years experience in Contracts or Proposals or equivalent combination of education, training, and experience.; Req
• Knowledge of CRO Industry.
• Excellent knowledge of Microsoft Excel, Word and understanding of costing models.
• Excellent knowledge of contract, proposals and budget processes and ability to interpret budgets and protocols.
• Possess strong analytical skills and excellent verbal and written communication skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.

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JOB DESCRIPTION

The Site Activation Manager (SAM) position within GSA team in IQVIA is our project manager for the start-up phase in charge of design and implementation of our strategy towards sites activation from award until open to enrolment. The SAM leads and oversees our country operations teams ensuring that our client commitments are delivered timely and according to project scope and processes. Additionally, for the assigned projects, the SAM represents the country site activation operations team to our internal project members and clients. The key project team members that the SAM interacts are the project manager, the clinical lead, a regulatory and contract and budget solution advisors and the country regulatory specialists. The SAM also counts on a rich regulatory intelligence database and best in class systems to enable the start up strategy execution.
The SAM is a fundamental role to deliver our clinical trial portfolio and belongs to a global unit with vast career growth opportunities.

Typical day to day includes working on 1-2 projects or a same client program performing the following activities:

• Participation of pre award and bid defense meeting activities providing start up expertise input for the project strategy.
• Upon award, develop the site activation delivery strategy according to project scope and specifics, indicating the activation projection for sites in diverse countries, site identification, regulatory, contract and start up elements’ timelines.
• Oversee the execution of site activation strategy, focusing in delivering sites in the agreed timeline, budget and within scope, pro-actively identifying and addressing risks.
• Communication with client, project team members and local regulatory specialists on study sites status, activation projections, risks, and opportunities to secure the activation strategy.
• 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.

Required Knowledge, Skills and Abilities

• B Sc Degree in Life Sciences or related field
• 5 - 7 years of proven experience managing projects in a scientific or clinical environment.
• Experience in an international environment preferred.
• Requires experience in leading projects in a cross-functional team.
• Strong leadership competencies to lead projects and multi-cultural teams.
• Project ownership controlling delivery on time, within scope and controlling budget.
• Demonstrable experience working on multiple projects or clients balancing competing priorities.
• Strong communication skills with the ability to negotiated and challenge decisions.
• Good regulatory and technical writing skills.
• Excellent understanding of study financial management.
• Proven ability to work on multiple projects balancing competing priorities.
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
• Proven ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.

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JOB DESCRIPTION

External Job Description

We are looking for a highly motivated and experienced Data Alignment Analyst.

role is to deliver accurate data for site payments, spanning multiple IQVIA proprietary systems. they must have end-to-end understanding of the data flows and system handoffs.

They will be a point of contact for IT groups and Payments groups.

Output results in successful set-up of the financial systems for a study that ensures accurate & on-time site payment data for all IQVIA studies, regardless of system used for payment (IQVIA CTMS or IQVIA InSite).

• Ability to review, assess and recommend legal language for Clinical Trial Agreements, Amendments or Notification Letters. Identify issues with contract language that is not cohesive with successful study set up.
• Proactively collaborate with key stakeholders and sponsors to ensure financial systems are aligned properly.
• Lead Project teams through escalations and interface issues, project managing stakeholders to solution
• Ability to represent the payments group globally, when speaking to sponsors / internal stakeholders (i.e.: global/regional PL & CSMG)
• Hold training calls with key project stakeholders to cover IPA start-up processes
• Review, analyze, and action metrics to ensure payment system set up is accurate so payments are made in a timely / efficient manner to avoid site escalations 
• Review and analyze payment system set-up and interface issues, and develop plan of action to correct / work around the associated issues  
• Work independently and prioritize workload to meet deadlines/KPIs
• Interpret and understand EDC subject visit data, site contracts and the payment system design & payment triggers. Analyse data fallout and provide any necessary corrections to ensure sites are paid accurately.
• Be able to identify data flow issues on large, complex, and ongoing studies; route these to the appropriate teams for action and see the issues through to resolution. Project manage stakeholders involved in the process including the coordination of accurate payment reconciliations.

What we’re looking for

• 1 year experience of data systems, data analysis, tools and processes. Preferably within the Clinical Trial Site Payments or Clinical Trial Operations environment (EDC and Site Payment Systems)
• Ideally experienced across aspects of the site payment lifecycle: data setup, contract setup, system setup, payment generation, site-facing experience & understanding of how sites are impacted by payments.
• Intermediate to advanced Excel skills with understanding/ability of writing logic statements.
• Ability to communicate complex project plans upwards with a simple messaging
• Problem solving - someone that can ‘think outside the box’ and would consider themselves a logical thinker.
• Fast learner and can keep up with every changing and evolving processes.
• Extremely process oriented – ability to step methodically through a business process or system process, and understand what is broken, the root cause, the corrective action and the preventative action
• Excellent verbal and written communication skills, with confidence attending and hosting calls.
• Exceptional ability to communicate remotely (via teleconferencing). Exceptional ability to learn from remote training (via teleconferencing & screen sharing). Exceptional ability to work productively in a global team, with colleagues & peers in multiple disparate locations.