Study Start-Up Operations Lead

GSK; Johannesburg; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A global biopharma company is seeking a Study Start-Up Operations Lead in Johannesburg, South Africa to manage study start-up activities for clinical studies. Responsibilities include coordinating teams, preparing regulatory submissions, and ensuring compliance with local regulations. Ideal candidates will have a Bachelor’s degree in life sciences, at least 3 years of relevant experience, and strong project management skills. This is an on-site role that offers significant growth opportunities.

Qualifications

• 3+ years experience in clinical research or clinical operations focused on study start-up.
• Knowledge of South African regulatory and ethics processes and ICH-GCP principles.
• Experience managing vendors and multiple stakeholders.

Responsibilities

• Lead study start-up operations for global clinical studies.
• Coordinate timelines, resources, and deliverables.
• Negotiate study budgets and maintain trial master file accuracy.

Skills

Project management skills

Written and verbal communication in English

Problem-solving skills

Vendor management

Education

Bachelor’s degree in life sciences, clinical research, pharmacy, nursing, or related field

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.

Find out more: Our approach to R&D

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 escape 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.

Responsibilites:

• 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.

Why you?

You are ready to make a meaningful contribution and grow your career. If you are ready to make a meaningful contribution and grow your career, we encourage you to apply.

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.

What we offer

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.

How to apply

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.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

Contact information:

You may apply for this position online by selecting the Apply now button.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.