Clinical Research Manager (Wits RHI)

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

Main Purpose of the Job:

• Ensure compliant, timely and cost-efficient delivery of clinical projects/ trials through technical input and ongoing review and evaluation of project performance, in collaboration with project teams

Location:

• 57 Klein Street, Hillbrow, Johannesburg

Key Performance Areas:

Regulatory Oversight

• Regulatory submissions meeting national requirements
• Updated regulatory guidance to Stakeholders
• Audit-ready study files and eTMF compliance
• Regulatory compliance across projects

Programme Management

• Projects delivered on time and within scope
• Updated project management plans
• Performance dashboards and project metrics reports
• Accurate status reports for stakeholders and management

Quality Assurance and Risk Management

• Identify and mitigate clinical, operational and compliance risks
• Ensure implementation of CAPA where required

Staff Management and Capacity Development

• Competent and developed team members
• Achievement of staff performance objectives
• Effective staff utilisation
• Positive labour relations and teamwork

Effective Self-Management and Performance Ownership

• Tasks completed within agreed timelines
• Effective Stakeholder communication
• Continuous professional development
• Demonstration of organisational values and positive

Required Minimum Education and Training:

• Master’s Degree in Science, Health or related field

Required Minimum Work Experience:

• Minimum of 10 years’ clinical trials experience with sound regulatory affairs expertise and clinical trial management experience
• At least 3-5 years’ experience in a leadership / management role

Desirable Additional Education, Work Experience and Personal Abilities:

• PhD
• Extensive experience with Network Studies

Please note:

• WHC, in accordance with its Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto
• AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium