Senior Clinical Trials Management Associate

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases
around the world. Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation.
Kite, a Gilead Company, is a biopharmaceutical company that is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.

The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Kite/Gilead’s products.
For the team based in our European Headquarters in Stockley Park, Uxbridge, we are looking for a Senior Clinical Trials Management Associate to work within the Oncology Disease/Cell Therapy therapeutic area. The Senior CTMA will be based in Stockley Park with the team and be on site 3 days a week.

Job Functions:

• Assist global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
• Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to Gilead SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
• Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
• Review of trip reports generated by CRO CRAs.
• Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
• Assists in the Management of the CRO’s and vendor’s as required.
• Assists with the preparation and organization of international investigator meetings
• Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
• Performs administrative duties in a timely manner as assigned.
• Travel could be up to 20%.

Experience, knowledge and skills:

• Educated to degree level or equivalent in a scientific discipline
• Previous experience of pharmaceutical clinical trial experience
• CRA experience is highly desired
• Oncology experience is desirable
• Excellent verbal, written, interpersonal and presentation skills are required.
• Must be familiar with routine medical/scientific terminology.
• Must be proficient with Word, PowerPoint, and Excel.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.

Gilead Core Values

Integrity (always doing the right thing)
Teamwork (collaborating in good faith)
Excellence (working at a high level of commitment and capability)
Accountability (taking personal responsibility)
Inclusion (encouraging diversity)