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. Plays a pivotal role as a member of the local clinical study team. Responsible for contributing to the planning, execution, and delivery of the clinical trial in the country.

Determines the most appropriate submissions strategy in collaboration with the study team for regulatory and ethics committee submissions. Accountable for timely delivery of local regulatory and ethics submission content, including preparation, collation, review, tracking, and filing of documentation. Coordinates support from Clinical Support Specialists and maintains communication with Regulatory Affairs, Ethics Committees, and sites.

Supports local and central functions in country and site feasibility assessment and selection for new trials. Coordinates, negotiates, and executes investigator and supplier contracts in accordance with GSK SOPs and local legislation. Builds and manages study budgets using benchmarking data, handles updates for protocol amendments, and ensures TMF completeness.

Tracks and manages the study budget post-build, ensuring timely and accurate payments to sites and vendors via dedicated systems. Facilitates timely and secure delivery of clinical supplies and logistics. We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included.

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