Local Clinical Project Manager- IQVIA x1
Job Details
Job Title: Local Clinical Project Manager
Company: IQVIA
Job Reference: R1577610
Location: Bloemfontein, South Africa
Employment Type: Full-time
Work Arrangement: Home-based
Industry: Clinical Research and Healthcare
Salary: Not specified in the supplied advertisement
Application Status: Applications open through the official careers portal.
Job Description
IQVIA is seeking an experienced Local Clinical Project Manager to lead and coordinate clinical study teams at country level in South Africa.
The successful candidate will be responsible for ensuring that clinical trials are delivered according to agreed timelines, budgets, quality standards and regulatory requirements. The role involves managing local study teams, coordinating clinical trial sites, overseeing monitoring activities and ensuring compliance with Sponsor Procedural Documents, International Council for Harmonisation – Good Clinical Practice (ICH-GCP) guidelines and applicable local regulations.
The appointed candidate may also perform site monitoring activities when required to support the organisation’s flexible capacity model.
This position is particularly suited to a professional with clinical project management experience, strong leadership abilities and knowledge of clinical research processes, preferably within the oncology therapeutic area.
Key Duties and Responsibilities
The Local Clinical Project Manager will be responsible for the following:
Clinical Study Management
Take overall responsibility for clinical study commitments within South Africa.
Ensure timely delivery of clinical trial data according to required quality standards.
Lead and manage Local Study Teams, including Clinical Research Associates (CRAs) and Clinical Study Associates (CSAs).
Ensure that clinical studies comply with sponsor procedures, ICH-GCP guidelines and local regulatory requirements.
Assess the clinical and operational feasibility of proposed studies.
Clinical Trial Site Management
Identify suitable clinical trial sites and investigators.
Conduct initial Site Quality Risk Assessments.
Perform Site Qualification Visits to evaluate the suitability and quality risks of potential sites.
Ensure that trial sites are properly selected, qualified, initiated, monitored and closed.
Ensure that all essential clinical trial documentation is collected and archived.
Regulatory and Documentation Management
Coordinate timely submission of applications and documentation to Ethics Committees (ECs) and Institutional Review Boards (IRBs).
Work with Regulatory Affairs to ensure timely submissions to relevant regulatory authorities.
Prepare and manage country-level financial Study Management Agreements (fSMAs).
Maintain accurate clinical study budgets within the sponsor’s financial systems.
Prepare local Master Clinical Study Agreements (CSAs), including site budgets and amendments.
Coordinate the preparation of country-level Master Informed Consent Forms (MICFs) and site-level Informed Consent Forms (ICFs).
Arrange relevant translations where required.
Ensure that all essential study documents comply with ICH-GCP requirements.
Clinical Trial Operations
Plan and coordinate local clinical trial drug activities, including purchasing, reimbursement and drug destruction.
Set up and maintain clinical studies in Clinical Trial Management Systems (CTMS).
Maintain local study websites where required by legislation.
Coordinate and oversee clinical trial monitoring activities from site activation to study closure.
Ensure monitoring activities comply with approved Monitoring Plans.
Review monitoring visit reports and provide guidance to Clinical Research Associates.
Conduct co-monitoring, accompanied site visits and training visits when required.
Leadership and Risk Management
Identify potential study risks and resolve complex clinical trial challenges.
Lead, motivate and support cross-functional study teams.
Organise regular Local Study Team meetings and ensure that discussions follow structured agendas.
Monitor study progress against timelines, budgets and quality requirements.
Provide guidance to team members to support successful clinical trial delivery.
Minimum Requirements and Qualifications
Applicants must meet the following requirements:
Bachelor’s degree in a relevant discipline, preferably in Life Sciences, or an equivalent qualification.
At least one year of experience in Local Clinical Project Management.
Very good knowledge of the oncology therapeutic area.
Proven ability to lead and motivate cross-functional teams.
Experience delivering clinical trials within agreed timelines, budgets and quality standards.
Excellent understanding of clinical study processes, including clinical trial monitoring.
Strong project management skills.
Very good spoken and written English communication skills.
Ability to learn and adapt to different information technology systems.
Willingness and ability to travel nationally and internationally when required.
Required Skills and Competencies
The ideal candidate should demonstrate:
Clinical project management and coordination skills.
Strong leadership and team management abilities.
Knowledge of clinical research and trial monitoring processes.
Understanding of ICH-GCP guidelines and regulatory compliance.
Knowledge of oncology clinical research.
Excellent planning and organisational skills.
Ability to manage multiple tasks and competing priorities.
Strong attention to detail and accuracy.
Problem-solving and risk management abilities.
Negotiation and stakeholder management skills.
Ability to work independently and collaboratively.
Adaptability when working with clinical research systems and technology.
Ability to manage projects within agreed budgets and deadlines.
Important Conditions of Employment
The position is full-time and home-based.
The successful candidate must be based in one of the locations listed in the vacancy.
IQVIA has specifically stated that applications from candidates based outside the advertised locations will not be considered.
National and international travel may be required.
The successful candidate must be able to coordinate clinical study teams and trial activities across different sites.