Study Start-Up Operations Lead

683 GlaxoSmithKline South Africa (Pty) Limited; Johannesburg; On-site; ZAR 500 000 - 700 000; Full time

Job summary

A leading pharmaceutical company in Johannesburg is seeking a Study Start-Up Operations Lead to coordinate study start-up activities for global clinical studies. This role involves managing local teams, vendors, and site relationships to ensure timely submissions of regulatory and ethics documents. The ideal candidate will have a Bachelor's degree in life sciences and at least 3 years of experience in clinical research. Strong project management and communication skills are essential for success. Occasional travel may be required within the region.

Qualifications

• 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.
• Experience managing vendors, sites and multiple stakeholders.

Responsibilities

• Act as the operational lead for study start-up activities.
• Plan and manage site selection and feasibility activities.
• Prepare and coordinate regulatory authority and ethics committee submissions.

Skills

Project management

Regulatory knowledge

Communication skills

Education

Bachelor’s degree in life sciences

Advanced degree in life sciences

Job description

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Study Start‑Up Operations Lead

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. We value clear communication, practical problem solving, and a focus on patient safety. This role offers growth, visible impact and the chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together.

This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following :

• 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 elevate 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.

Responsibilities

• 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 Qualifications

• 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 Qualifications

• 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.

What we Offer

If this role matches your experience and career goals, please submit your CV and a brief cover note explaining why you are interested. We are excited to learn about what you will bring to our team.