Clinical Operations Specialist

Leads the co-ordination and delivery of specialized operational activities according to ICH GCP, international and local regulations, and relevant GSK written standards. The Clinical Operations Specialist plays a pivotal role as a member of the local clinical study team and is responsible for contributing to the planning, execution, and delivery of the Clinical trial in the country.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpageLife at GSK | GSK

In this role you will

Submissions

• Be responsible for determining the most appropriate submissions strategy for the study in collaboration with the study team; provides consult to the study team to ensure best possible outcome for regulatory and/or ethics committee submissions and learns from past outcomes to continually improve future submissions.

• Be accountable for timely delivery of local regulatory and/or ethics submission content and for the preparation, collation, review, tracking and filing of all documentation required (e.g., ICF review, coordinating translations, central/national ethics packages, delivery to sites); coordinates support of Clinical Support Specialists as needed and maintains communication with Regulatory Affairs/Ministries of Health, National/Central Ethics Committees and sites.

Study Feasibility

• Be responsible for supporting local and central functions to lead the country and/or site feasibility assessment and site selection for new trials while actively working with stakeholders to simplify/optimize processes.

Contracts and Other Legal Documents

• Be responsible for coordinating, negotiating and executing investigator and supplier contracts and other legal documents for clinical operations in accordance with GSK SOPs and local legislation. May be involved or bring support to the CROs for fully outsourced studies in-country where applicable.

• Act as clinical operations expert/point of contact on any contracting/legal issues, SOP interpretation, dispute resolution and proactively identifies areas of risk. Develops training materials and actively train/coach/mentor staff on contracting procedures/processes applicable to clinical research.

Budget Development and Negotiation

• Be responsible for building the study budget using benchmarking and historical data and in accordance with local requirements.

• Be responsible for managing budget updates for protocol amendments and ensuring TMF completeness for all budget and contracting activities.

Financial analysis, Forecasting and Payments

• Be responsible for tracking and managing the study budget in country once the study budget build is complete.

• Be responsible for ensuring timely and accurate payments to investigator sites/vendors as per the agreed contract. Will set-up, input and manage the payment schedule within dedicated systems and prepare purchase orders or task orders for services.

Clinical Supplies and Logistics

• Be accountable for facilitating timely and secure delivery of clinical trial material, ancillary study supplies and devices to clinical sites in collaboration with suppliers, local depot, customs brokers, couriers, and GSK teams. May prepare and/or review importation documentation and maintains oversight of supply logistics, including cold chain requirements. May also be responsible for export of supplies or equipment and IMP distribution/destruction via local depot.

• Be responsible for oversight of vendor(s) managing local clinical supplies storage, supply distribution and destruction. May be required to purchase clinical trial supplies locally. Works with procurement and prepares purchase orders or task orders for services and supplies. Acts as business owner for local contracts and purchase orders related to clinical and ancillary supplies and IMP local depot where applicable. As needed, coordinates the support of clinical support specialists in preparation, tracking system updates and filing of documents.

• May act as IMP cold chain specialist being accountable for the vaccine IMP cold chain end to end management.

Other Clinical Operation Specialist Responsibilities

• Be responsible for coordinating and updating information in tracking systems (eg local safety databases) or as required for institutional reports and external stakeholders

• Manage local administrative activities related to training.

• Be responsible for archiving at the end of study in accordance with relevant GSK SOPs, policies and local regulatory requirements.

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.

• Experience in clinical research operations or similar positions in the pharmaceutical industry.

• Solid knowledge of ICH-GCP, local regulations, and regulatory processes.

• Excellent understanding of the external clinical trial environment and clinical trial start up processes for the UK.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations

Closing Date for Applications – 19th of May 2026 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

As a focused biopharma company, we discover, develop and deliver medicines and vaccines to create value for patients and shareholders. We are on track to make a positive impact on the health of 2.5 billion people by the end of the decade. In R&D, we combine the science of the immune system with advanced technologies to develop new medicines and vaccines that can help transform people’s lives. We focus on four areas – respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – where we have the strongest expertise and significant patient need remains. By developing differentiated medicines and vaccines across these areas, we can deliver patient benefit at scale and generate value for people, health systems, shareholders and society.

Find out more:

Our approach to R&D.

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Why GSK?

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

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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