Career Opportunities at IQVIA

• IQVIA is looking to appoint statistical programmers to utilize the SAS programming language to develop clinical study report materials according to the objectives of a clinical trial for regulatory submissions. Programming and performing related tasks serving the full spectrum of statistical programming needs in our DS3 environment (home or office based):

Responsibilities:

• Import data from various sources
• Program quality control checks for source data and reporting data issues
• Interpret project level requirements and develop programming specifications
• Write programming code following established Good Programming Practices
• Program SDTM and ADaM datasets
• Program to create statistical analysis tables, listing and figures
• Validate datasets and all statistical outputs per prescribed gate checks
• Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines
• Use and promote the use of established standards, SOPs, and standard methodologies
• Export data and clinical study report materials
• Provide training and mentoring to team members and department staff

THE PERSON

• We know that meaningful results require not only the right approach, but also the right people. Candidates should possess a Master’s or Bachelor’s degree in Biostatistics, Statistics, Mathematics, or Computer Science, and have a strong educational or practical evidence in programming.

Key required skills include:

• 3+ experience in Statistical Programmer role from CRO
• Excellent accuracy, attention to detail, problem solving, organizational as well as interpersonal communication.
• In light of the above, candidates for the roles should exhibit the following skills and competencies:
• Experience in programming in SAS within the CRO/Pharma/Biotech/Healthcare industries
• Knowledge of statistics and exhibit routine and occasionally complex analytical skills
• A focus on quality, accuracy, and completeness of work activities
• Excellent communication skills
• A good understanding of Good Clinical Practice and ICH guidelines
• Ability to independently lead (or have lead potential) and estimate programming scope of work, handle resource assignments, communicate work status, and work within project timelines for deliverables
• Take initiative and can be counted on to get the job done, with integrity
• Have the self-awareness to recognize when negotiating skills and assistance are needed
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients

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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 4 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.

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BASIC FUNCTIONS:

• Works with Clinical Operations Management staff to ensure the successful management, performance, and career development of Clinical Trial Managers. Provides training and consultation related to clinical operating activities in the conduct of clinical trial projects. Serves as a source of clinical research expertise for IQVIA Biotech clinical staff. Contributes to, and participates in, the marketing of IQVIA Biotech services. Assures compliance with Good Clinical Practices (GCPs), ICH, Standard Operating Procedures (SOPs), Working Practices (WPs), and policies and procedures set forth by IQVIA Biotech and its clients.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Responsible for the following activities:

• Clinical Staff Line Management Duties/Responsibilities:
• Line management for assigned CTMs, (both office and regionally based) in the following areas:
• Plans career development of staff.
• Anticipates resource issues and plan remedial action.
• Communicates with the CTMs as needed, to ensure correct monitoring resources per project.
• Liaise with Project Managers to ensure monitoring deliverables/targets are met, ensure project hours are met, ensure excessive total hours are noted and action taken as necessary.
• Ensures any project issues and results of discussions with Project Managers and are escalated appropriately.
• In coordination with the Director, Clinical Operations ensures proper allocation of Operations resources.
• Assesses training requirements for monitoring staff.
• Organizes appropriate training in liaison with the IQVIA Biotech e-process and Integration (Training) Department. Monitors and records subsequent performance to assess the effects of training on efficiency.
• Conducts field evaluation visits with staff at sites.
• Holds regular one-on-one meetings with staff to discuss performance.
• Writes and delivers performance appraisals.
• Reviews and approve time sheets and expense reports as required.
• Coach, train, and support direct reports:
• Provides staff with expert clinical research and therapeutic advice.
• Assists with organizing and conducting Lead CRA, CTM and CRA Staff Meetings at regular intervals.
• Addresses issues discovered at meetings.
• Maintains an awareness of company policies to effectively represent the company perspective to clinical staff.
• Identifies training needs and ensure staff participation during in-house training activities as required.
• Collaborates with Director, Clinical Operations to develop and administer an effective orientation/on-boarding process for new CTM, Lead CRA and CRA hires.
• Maintains awareness of overall development in the field of clinical research and ensures that staff remains current on clinical monitoring developments.

Clinical Operations Department Duties/Responsibilities:

• Assists Clinical Operations Management with review and revision of departmental SOPs, working practices, and policies.
• Assists Clinical Operations Management with interviewing and making hiring recommendations and/or decisions on new staff.
• Communicates staff increase and equipment needs to Director, Clinical Operations.
• Communicates staff training needs to Director, Clinical Operations.
• Assists Director, Clinical Operations to create and deliver new department initiatives, improvement plans or training
• Assists Director, Clinical Operations with development of strategic departmental goals which correlate with corporate goals and formalize departmental action plans to meet those goals.
• Assists in developing department budget and is accountable for the profit/loss and the overall financial performance of the Clinical department.
• Assists Director, Clinical Operations with Process Improvement Plans and other special projects as required by the department.
• Provides clinical management oversight of clinical projects to ensure consistent on-time completion of client deliverables and timely escalation and resolution of issues.
• Collaborates with other department and/or functional groups to ensure consistency of processes.

Project Duties/Responsibilities:

• May serve as CTM for projects as directed.
• Assists CTMs with defining the scope of work with the clinical monitoring team.
• Assists CTMs with identifying changes in scope.
• Provides vacation coverage for CTMs as required.
• Provides clinical expertise to project team as needed.

Business Development Duties/Responsibilities:

• Participate in the development of the clinical portion of client proposals including preparation of clinical project budget and text.
• Preparation for and attendance at capabilities and bid defense meetings.
• Participate in marketing activities, client presentations, and proposal development.
• Participate in and/or attend professional and industry meetings as a representative of IQVIA Biotech.

KNOWLEDGE, SKILLS & ABILITIES:

• Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff.
• Ability to balance needs of the organization with needs of staff.
• Ability to protect confidential/sensitive information.
• Ability to manage multiple priorities within the department and across staff.
• Ability to reason independently for assessing and recommending specific solutions in clinical settings.
• Ability to mentor and train clinical staff.
• Understanding of basic data processing functions, including electronic data capture.
• Working knowledge of Word, Excel, and Power Point.
• Working knowledge of current ICH/GCP guidelines and applicable country specific regulations.
• Able to qualify for a major credit card.
• Valid driver’s license; ability to rent automobile.
• Willingness and ability to travel domestically and internationally as required.

MINIMUM RECRUITMENT STANDARDS:

• Excellent organizational, communication (verbal and written), and interpersonal skills.
• Ability to work independently, prioritize and function effectively within a matrix team environment.
• Working knowledge of Word, Excel, and Power Point.
• Prior global/multi region trial management experience is required.
• Prior proposal development and bid defense participation is preferred.
• Prior budget development and management experience is preferred.
• Prior experience in electronic data capture (EDC) is preferred.
• Prior site management experience is required.
• Prior project team leadership/management is required.
• Prior vendor management experience is preferred.
• Prior experience in a Clinical Research Organization (CRO) is preferred.

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PURPOSE

• Sales Manager manages the team of Key Accounts Managers.
• The induvial must be able to collaborate with all internal departments to achieve business goals.
• Their main responsibility is to build a high performing team that drives innovation and is responsible for achieving Quarterly and YTD targets.

Responsibilities

• Achieving company sales targets for both base and growth
• Build a highly motivated performing Key Accounts Management team
• Tracking performance of the Key Accounts Managers and providing regular feedback on progress
• Devise strategies and techniques necessary to achieve the sales targets
• Working closely with the Consulting team to see how best we can offer solutions to clients, promote our consulting capabilities and upskilling of the sales team
• Use the Global Account Planning to leverage ideas and input for local account plans
• Map stakeholders in each account, identify potential customers and generate new sales leads
• Weekly completion and management of the roadmap
• Responsibility for quarter end closure and ensuring that all opportunities are in hand
• Thorough understanding of the RIH file and the Daily change report
• SIP Allocation and communication of achievements to regional finance and team
• Assist KAM's with contract renewals and negotiating process and tracking the progress of contract renewals
• Setting objectives for each KAM, monitoring ongoing progress and completion of competency reviews
• Approve expenses and leave of team members
• In field training, development and coaching of KAM's
• Clear understanding product offerings and ongoing enhancements to remain relevant
• Understand competitor activity and suggest strategies to counter act competitors
• Yearly budget setting and forecasting that involves target setting for KAM's
• Assist with preparation and input for Quarterly Country review for the Commercial sales team

Job Requirements:

• 3-5 Years of previous experience in managing people
• Strong Pharmaceutical industry experience and an understanding of the nuances of the SA Healthcare sector
• Experience in Analytics and exposure to using IQVIA data, products and services would be beneficial
• Strong experience in managing Key Accounts Management would be an advantage
• Basic analytical ability to assess challenges and provide solutions
• Very strong drive to meet client needs and operate with sense of urgency to meet deadlines
• Strong ability to expand their knowledge and continuously grow
• Strong communicator

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• As Project Leader/ Senior Project Leader you will manage cross functional teams and liaise directly between IQVIA 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, the Project Management Analyst for project coordination, tracking and financial analysis, the CRA for site coordination, Medical Advisor for subject safety oversight and the Data Team Lead, Biostatistician and Pharmacokineticist for analysis and reporting.
• This is an important and high-profile role within our Research & Development Operation and IQVIA’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.
• Managing the Phase I or Investigator site(s)
• 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 ideal.
• Minimum 2-4 years prior project management experience and experience in clinical operations; or equivalent combination of education, training and experience
• In depth knowledge of early phase study designs, clinical pharmacology, pharmacokinetics, pharmacodynamics and therapeutic knowledge in any of the following areas would be an advantage: neuro-degenerative, psychiatric or dermatological disorders; vaccines.

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• As Project Leader/ Senior Project Leader you will manage cross functional teams and liaise directly between IQVIA 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’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 ideal.
• Minimum 2-4 years prior project management experience and experience in clinical operations; or equivalent combination of education, training and experience
• In depth therapeutic knowledge in one or more of the following areas: Cardiovascular, Renal and Metabolic Diseases, would be an advantage