Senior Clinical Trials Program Manager & Regulatory Lead

AJ Personnel; Gauteng; On-site; ZAR 1,000,000 - 1,500,000; Full time

Job summary

Wits Health Consortium in South Africa seeks an experienced leader to ensure compliant, timely and cost-efficient delivery of clinical projects and trials through regulatory input, ongoing review and collaboration with project teams.

The role emphasizes regulatory submissions, audit-ready study files, CAPA implementation, risk management, staff development, and stakeholder reporting, supported by a Master’s degree and a track record of 10+ years in clinical trials.

Qualifications

• Master’s degree in Science, Health or related field is required.
• Minimum 10 years’ clinical trials experience with regulatory affairs and trial management.
• At least 3–5 years in a leadership/management role.
• Desirable: PhD and extensive experience with Network Studies.

Responsibilities

• Oversee regulatory submissions to meet national requirements.
• Lead programme management to deliver projects on time and within scope.
• Identify and mitigate clinical, operational and compliance risks; drive CAPA.
• Manage staff performance, development and utilization; ensure strong team dynamics.
• Maintain effective stakeholder communication and performance dashboards.

Skills

Leadership

Regulatory affairs

Clinical trial management

Stakeholder communication

Education

Master’s Degree in Science, Health or related field

Job description

Wits Health Consortium in South Africa seeks an experienced leader to ensure compliant, timely and cost-efficient delivery of clinical projects and trials through regulatory input, ongoing review and collaboration with project teams.

The role emphasizes regulatory submissions, audit-ready study files, CAPA implementation, risk management, staff development, and stakeholder reporting, supported by a Master’s degree and a track record of 10+ years in clinical trials.