Clinical Operations Specialist (Contracts)

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.

As Clinical Operations Specialist (Contracts), you will lead the co-ordination and delivery of specialised operational activities according to ICH GCP, international and local regulations, and relevant GSK written standards. You will play a pivotal role as a member of the local clinical study team and are responsible for contributing to the planning, execution, and delivery of the Clinical trial in the country. This role offers visible career growth, a chance to shape ways of working, and meaningful impact while 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:

• Responsible for coordinating and controlling contracts and other legal documents for clinical operations, communicating updates, and documenting activities in accordance with GSK SOPs and local legislation in-country and for CRO-managed Country/ies where applicable.
• May be involved or bring support to the CROs for fully outsourced studies in-country and in CRO-managed Country/ies where applicable.
• Accountable for negotiation and execution of investigator and supplier contracts and amendments.
• Responsible for ensuring all contractual terms and conditions are based on the approved GSK Master template.
• Accountable for negotiation and execution of other legal documents which may include, Confidential Disclosure Agreements, ICF compensation clause changes and Data Privacy clause changes.
• Develop and maintain accurate tracking information related to contracts, CDAs, compensation clauses, and external costs.
• Responsible for collaborating with legal counsel and procurement to maintain Clinical Operations Master templates and service agreements (including site templates), and updating templates as required.
• Ensures due diligence, TPO/TPR management of third-party suppliers is complete prior to execution of any contractual agreement.
• Acts as clinical operations expert/point of contact on any contracting/legal issues, SOP interpretation, dispute resolution and proactively identifies areas of risk to Management.
• Develops training materials and actively train/coach/mentor staff on contracting procedures/processes applicable to clinical research.
• Own the entire contract lifecycle - intake, version control, execution, performance tracking, renewals, and termination - using modern Contract Lifecycle Management (CLM) tools.
• Responsible for reviewing benchmarking and historical data to complete the study budget build in collaboration with the Local Delivery Lead.
• Responsible for leading the budget development and negotiation process with the site or supplier, ensuring fair market value and consistency while optimizing cost and minimizing risk.
• Responsible for any budget updates because of protocol amendments.
• Acts as consultant/expert resource with respect to study budget development and any associated systems/tools, including identifying cost variances and opportunities for cost avoidance.
• Responsible for ensuring TMF completeness for all budget and contracting activities.
• Responsible for coordinating and updating information required for institutional reports and external stakeholders.
• Could act as subject matter expert at the LOC for different applications applicable to their role.
• Provide administrative support to the local GMASE department by coordinating meetings, managing communication flows, acting as the liaison between local and global teams, and performing related administrative duties.
• Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree, or equivalent, or relevant experience in clinical operations or similar positions in the pharmaceutical industry.
• Solid knowledge of ICH-GCP, local regulations, and regulatory processes.
• Experience in the UK National Contract Value Review (NCVR) process and proficiency with the CPMS platform.
• Experience working with the HRA (Health Research Authority) model agreements and IPHA (Irish Pharmaceutical Healthcare Association) contract templates.
• Excellent understanding of the external clinical trial environment and UK clinical trials regulations and start-up processes.
• Flexible and responsive to new ideas in a changing environment.

If you have the following characteristics, it would be a plus:

• Enthusiasm for AI-enabled tools and digital solutions to improve efficiency, data quality, and decision-making in clinical trial operations.
• Strong communication skills and relationship management abilities.

We welcome people from different backgrounds and life experiences. We support an inclusive workplace where everyone can contribute and grow. We look for colleagues who act with integrity, communicate openly and help each other succeed. You will have room to grow your skills, take on responsibility, and make a direct contribution to how we generate evidence.