Clinical Project Manager

ASSIGNMENT LENGTH: 3 year fixed-term contract

The Clinical Project Manager is responsible for the oversight and management of clinical programs, ensuring that studies are executed on time, within budget, and in compliance with all applicable regulations. This role provides leadership and coordination across functional teams and external partners, including Contract Research Organizations (CROs), and ensures the smooth execution of clinical trials from planning through study closeout. The role also involves site management and liaison activities to ensure high-quality conduct of clinical studies.

RESPONSIBILITIES:

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily:

Clinical Project Management:

• Lead the development, updating, and adherence to the Study/Trial Project Plan and implementation of the study.
• Act as the primary point of contact and coordinator for all functional areas involved in clinical trials.
• Lead internal and external project team meetings and facilitate cross-functional collaboration.
• Serve as the main point of contact for all CROs and oversee their activities to ensure quality and timelines are met.
• Lead scheduling and coordination of activities with CROs.
• Oversee Trial Master File (TMF) development and maintenance.
• Coordinate the development of Manuals of Procedures (MOPs) and Site-Specific Protocols (SSPs).
• Coordinate investigator meetings and ensure effective communication across clinical research study sites.
  
  Support the development of Clinical Study Reports (CSRs).
• Lead protocol development and revisions.
• Support and monitor ethics and regulatory submissions and approvals.
• Manage study budgets and ensure adherence to financial plans.
• In conjunction with the community engagement manager, ensure robust community engagement activities are planned, executed and evaluated.
• Ensure all trial procedures are implemented according to the relevant Good Clinical Practice, Data Protection Guidelines and SOPs.
• Monitor budget to allow efficient and accurate budget management
• Supervisory responsibilities, including managing team members' day-to-day activities, providing guidance and support, monitoring performance, and contributing to their professional development.

Site and Operational Management:

• Coordinate site development, including site selection, feasibility assessments, and site initiation activities.
• Provide site training and ongoing support to ensure protocol adherence and regulatory compliance.
• Act as the liaison for clinical supplies, site pharmacies, and laboratory coordination.
• Ensure high-quality data collection and site compliance throughout the study lifecycle.

QUALIFICATIONS:

Education/Experience

• Relevant Bachelor's degree; advanced degree preferred.
• Minimum of 7 years' experience in clinical research, including clinical trial management, project management, and clinical research site oversight.
• Minimum of 5-7 years in managing clinical research projects.
• Knowledge of MS Project or similar software tools for project planning and monitoring
• Experience managing CROs and cross-functional project teams.
• In-depth knowledge of ICH-GCP guidelines, local regulations, and international clinical trial requirements.
• Experience in reproductive health, HIV, or related therapeutic areas is essential.

Knowledge, Skills, and Abilities

• Leadership & Collaboration
• Problem-Solving & Decision-Making
• Budget Management
• Communication Skills
• Attention to Detail
• Adaptability

SALARY AND BENEFITS: Salary range depends on knowledge, skills and experience.

Excellent benefits package, including 90% of medical aid contribution (Discovery Health) for employee, spouse and up to 3 child dependents and 5% Provident fund contribution.

APPLICATION DEADLINE: 8 December 2025

The Population Council is an international, nonprofit, nongovernmental institution that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of country offices.