At a Glance
- Tasks: Lead clinical operations and manage contracts to drive impactful research.
- Company: Join GSK, a global biopharma leader with a mission to improve health.
- Benefits: Hybrid working, competitive salary, and opportunities for professional growth.
- Other info: Inclusive culture that values diverse backgrounds and experiences.
- Why this job: Make a real difference in healthcare while advancing your career.
- Qualifications: Bachelor’s degree or relevant experience in clinical operations required.
The predicted salary is between 40500 - 49500 £ per year.
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.
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 will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Contracts and Other Legal Documents
- 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.
- 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.
- Develop and maintain accurate tracking information related to contracts, CDAs, compensation clauses, and external costs.
- 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.
- Lifecycle Oversight
- Own the entire contract lifecycle – intake, version control, execution, performance tracking, renewals, and termination – using modern Contract Lifecycle Management (CLM) tools.
- Budget Development and Negotiation
- 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.
- 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.
- Other Clinical Operation Specialist Responsibilities
- 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.
This role is offered as hybrid working. You will combine remote work with regular time in a UK office and occasional site visits.
Basic Qualification
- 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.
Preferred Qualification
- 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.
If this role matches your skills and ambitions, we encourage you to apply. Tell us how your experience fits the role and let our recruitment team know if you need adjustments during the process.
Clinical Operations Specialist (NCVR & Contracts) in London employer: Gsk
GSK is an exceptional employer located in Greater London, offering a dynamic and inclusive work environment that fosters innovation and collaboration. As a Senior FinOps Product Manager, you will have the opportunity to drive impactful projects while benefiting from robust employee growth opportunities and a culture that values diverse perspectives. With a commitment to professional development and a focus on agile methodologies, GSK empowers its employees to thrive in their careers while contributing to meaningful advancements in cloud financial management.
