Medical Monitor
1 week ago
ASSIGNMENT LENGTH: 3 year fixed-term contract
DESCRIPTION:
The Medical Monitor / Research Physician is responsible for providing medical oversight and scientific expertise for clinical studies, ensuring that trials are conducted in accordance with protocol, regulatory requirements, and ethical standards. This role contributes to study design, protocol development, clinical monitoring, and analysis of medical data, and supports preparation of clinical study reports, manuscripts, and regulatory submissions. The Medical Monitor works closely with investigators, clinical teams, and safety physicians to maintain high-quality study conduct and patient safety.
RESPONSIBILITIES:
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily:
Protocol and Funding Proposal Development:
- Contribute to the development of funding proposals and initiate new proposals as needed.
- Respond to questions from Institutional Review Boards (IRBs) and National Regulatory Authorities (NRAs).
- Provide input into protocol development and study design.
Study Conduct and Clinical Oversight:
- Lead the development and review of clinical Standard Operating Procedures (SOPs).
- Contribute to the development of Manuals of Procedures (MOPs) and Site-Specific Protocols (SSPs).
- Provide input on Case Report Forms (CRFs) to ensure accurate medical data collection.
- Train internal Population Council teams and research sites on clinical procedures, in coordination with the Senior Clinical Program Manager.
- Conduct ongoing medical review and monitoring of study conduct, including interpretation of laboratory findings and clinical data in collaboration with investigators.
- Participate in advisory committee meetings such as DMC, DSMB, and PSRT.
- Liaise with the Medical Safety team on adverse event (AE) assessments.
- Review all medically related protocol deviations and ensure appropriate corrective actions
CSR and Manuscript Development:
- Provide input into statistical analysis plans.
- Review and provide input into Clinical Study Reports (CSRs).
- Initiate and contribute to scientific manuscripts related to study findings.
Additional Responsibilities:
- Mentor and train team members.
- Provide input into new research funding proposals.
- Conduct medical monitoring for other assigned projects.
- Serve as backup Safety Physician and Deputy QPPV (South Africa).
- Collaborate closely with cross-functional teams to ensure alignment between clinical, safety, and operational activities.
QUALIFICATIONS:
Education/Experience
- Medical degree (MD or equivalent) with registration with the appropriate medical council as a medical doctor.
- Minimum of 7–10 years' experience in clinical research, medical monitoring, and project oversight.
- Experience in clinical trial design, conduct, and medical safety.
- Experience in HIV research or reproductive health research is an advantage.
- Knowledge of ICH-GCP guidelines, local regulations, and international clinical trial standards.
Knowledge, Skills, and Abilities
- Collaboration
- Communication Skills
- Problem-Solving
- Adaptability & Flexibility
- Attention to Detail
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.
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