Overview
Study Start-Up Operations Lead Jobs in Sandton, South Africa at GSK
You will lead study start‑up operations in South Africa for global clinical studies. You will coordinate cross‑functional teams, local partners and vendors to deliver studies on time, to budget and to quality standards. You will work with global and local stakeholders and guide sites through regulatory and ethics submissions. The role offers growth, visible impact and the chance to contribute to GSK’s mission.
Responsibilities
- Act as the operational lead for study start‑up activities within South Africa, coordinating timelines, resources and deliverables.
- Manage local study teams, vendors and site relationships to complete regulatory and ethics submissions.
- Prepare and review study start‑up documents, including local operational plans, informed consent forms and site contracts.
- Track study milestones, identify risks, propose mitigation plans and escalation issues when needed.
- Maintain trial master file accuracy and ensure compliance with local regulations, ICH‑GCP and GSK standards.
- Support training and coaching of site and internal staff on start‑up processes and local requirements.
- Plan and manage site selection and feasibility activities in collaboration with global and local colleagues.
- Prepare and coordinate regulatory authority and ethics committee submissions and respond to queries.
- Negotiate study budgets, through to contracting.
- Maintain transparent updates to study teams and stakeholders on start‑up progress and risks.
- Contribute to process improvements and share best practices to strengthen start‑up efficiency.
Basic Qualification
- Bachelor’s degree in life sciences, clinical research, pharmacy, nursing or a related field.
- Minimum of 3 years’ experience in clinical research or clinical operations focused on study start‑up.
- Knowledge of local South African regulatory and ethics processes and ICH‑GCP principles.
- Experience managing vendors, sites and multiple stakeholders in a matrix environment.
- Strong project management skills, including planning, tracking and reporting study milestones.
- Clear written and verbal communication skills in English and ability to work on‑site in South Africa.
Preferred Qualification
- Advanced degree in life sciences or clinical research.
- Experience working in global pharmaceutical or vaccine clinical programmes.
- Familiarity with trial master file systems and clinical study systems.
- Prior experience negotiating site contracts and managing start‑up budgets.
- Demonstrated ability to lead local teams and coach colleagues.
- Practical problem solving and documented experience implementing risk mitigation plans.
Work Model
This role is on‑site in South Africa with occasional travel across the region as required.
Benefits
You will join a collaborative team focused on high‑quality study delivery and patient safety. You will gain exposure to global clinical programmes, develop leadership skills, and influence study operations. If you are ready to make a meaningful contribution and grow your career, we encourage you to apply.
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Title: Study Start-Up Operations Lead
Company: GSK
Location: Sandton, South Africa
Category: