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
• Be responsible for determining the most appropriate submissions strategy for the study in collaboration with the study team
• Be accountable for timely delivery of local regulatory and/or ethics submission content
• Be responsible for supporting local and central functions to lead the country and/or site feasibility assessment and site selection for new trials
• Be responsible for coordinating, negotiating and executing investigator and supplier contracts and other legal documents
• Act as clinical operations expert/point of contact on any contracting/legal issues
• Be responsible for building the study budget using benchmarking and historical data
• Be responsible for managing budget updates
• Be responsible for tracking and managing the study budget
• Be responsible for ensuring timely and accurate payments to investigator sites/vendors
• Be accountable for facilitating timely and secure delivery of clinical trial material
• Be responsible for oversight of vendor(s) managing local clinical supplies
• May act as IMP cold chain specialist
• Be responsible for coordinating and updating information in tracking systems
• Manage local administrative activities related to training
• Be responsible for archiving at the end of study

• 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

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

• Competitive base salary
• Annual bonus based on company performance
• Flexible working options
• Learning and career development
• Access to healthcare & wellbeing programmes
• Employee recognition programmes
• Pension plan membership
• Shares and savings programme