Jobs at Desmond Tutu Health Foundation

Requirements

• A master’s degree in health sciences or a related field
• 10+ years clinical research experience
• 5+ years senior QA/Regulatory leadership experience
• Demonstrated Sponsor-level oversight experience (Phase I–IIIb)
• Experience with SAHPRA inspections and regulatory submissions
• Strong executive communication and reporting capability
• Demonstrated experience leading multidisciplinary QA/Regulatory teams.
• Proven track record in staff performance management and capability development.
• Experience exercising functional oversight across multiple sites.
• Strong organisational leadership and change management capability
• Valid SA Drivers licence

Responsibilities:

Sponsor Governance (Phase I–IIIb)

• Develop, implement and continuously improve the Sponsor-level Clinical Quality Management Plan (CQMP).
• Approve and oversee trial-specific Monitoring Plans aligned to risk classification.
• Review monitoring reports and document Sponsor oversight decisions.
• Ensure formal delegation logs are maintained and reviewed.
• Oversee CRO/vendor performance and compliance.
• Ensure pre-study risk assessments and CtQ factor identification are completed.
• Maintain Sponsor Oversight Log and risk tracking system.

Implementing Site Governance (30+ Trials)

• Conduct bi-annual regulatory file reviews for all active studies.
• Review and track Sponsor monitoring findings and CAPAs.
• Perform cross-study deviation trend analysis.
• Oversee delegation logs and training documentation compliance.
• Conduct periodic source data verification spot-checks.
• Ensure site readiness for Sponsor and regulatory audits.

Regulatory & HREC Compliance

• Quality review all SAHPRA submissions prior to filing.
• Oversee substantial amendments, safety reports, and annual reports.
• Ensure UCT HREC submissions and continuing reviews are timely.
• Maintain regulatory intelligence tracker for SAHPRA and ICH updates.
• Coordinate regulatory inspection responses.

Pharmacovigilance & Safety Oversight

• Oversee SAE/SUSAR reporting processes.
• Ensure reconciliation between safety database and site reports.
• Review DSMB reports and track required actions.
• Conduct periodic safety trend reviews for high-enrolment studies.

Enterprise Risk Governance & Board Reporting

• Maintain enterprise clinical risk register.
• Prepare and present quarterly Quality & Regulatory Risk Dashboard to EXCO.
• Prepare bi-annual governance reports to the Board: A&R Committee.
• Escalate high-risk issues within defined timelines.
• Lead annual inspection simulation exercises.
• Identify organizational and individual training needs through skills audits and performance data

Quality Systems & Organizational Capability

• Maintain SOP lifecycle management system.
• Ensure ≥95% SOP review compliance within cycle.
• Develop and implement annual QA training plan.
• Conduct bi-annual Quality Workshops.
• Assess monitoring team competency annually.

Core Team Leadership & Site Regulatory Oversight

• Provide strategic leadership to the Core QA, Monitoring and Regulatory function, ensuring alignment to enterprise clinical risk priorities.
• Set annual departmental objectives aligned to enterprise risk and strategic KPAs, translate these into individual performance KPIs for each direct report, and lead structured quarterly performance reviews with documented feedback, accountability tracking, and defined development actions.
• Exercise functional oversight (non-line management) over site regulatory officers to ensure consistency of regulatory standards across all DTHF/C sites.
• Identify recurring regulatory deficiencies across sites and implement corrective training interventions.
• Provide formal feedback reports to Site Leadership on regulatory performance trends.
• Escalate systemic performance risks to EXCO where regulatory exposure increases.

Close: 13th March 2026

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Requirements

• MSc in biomedical science or medical degree
• 2-3 years’ experience as a clinical project manager running clinical trials
• Previous experience with site initiation, monitoring plans, safety reporting
• Experience with submissions to South African regulators and ethics committees
• Knowledge of Good Clinical Practice guidelines and clinical trial site processes
• Demonstrated leadership and people-management experience
• Strong planning, organization and reporting skills
• Budget/grant management skills
• Excellent scientific writing and communication skills (English written and verbal)
• High personal integrity, resilience, and attention to detail

Advantageous:

• Phase 1 infectious disease trial experience
• Multi-site trial experience
• Experience submitting to the South African Health Products Regulatory Authority
• Strong research focus and a publication record
• Experience with vaccine manufacturing processes
• Experience in scientific and grant writing
• PhD in a related speciality
• Competence in data management, biostatistics and data interpretation
• Familiarity with funding agency and sponsor reporting requirements

Responsibilities:

• Co-ordinate and oversee the implementation of an ambitious multi-site HIV vaccine programme
• Monitoring, evaluation and reporting on study progress
• Manage key project staff members ensuring deliverables are met
• Engage in the HIV Vaccine research agenda
• Assist the study principal investigators with preparing reports for funders and regulators
• Maintain relationships with all key stakeholders responsible for project delivery

Close: 06th March 2026