Senior Clinical Trials Management Associate

Gilead

Uxbridge, United Kingdom

Job Description

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 Uxbridge, we are looking for a Senior Clinical Trials Management Associate to work within the Oncology Disease/Cell Therapy therapeutic area. This is a hybrid working structure of 3 days per week in the office.

Essential Duties and 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 is required 1 or 2 times per year.

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 required/CAR-T Cell Therapy would be 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;
The candidate should be skilled in communication, time management, organization, and prioritization;
Previous experience in clinical research sites/hospitals, CROs, or pharmaceutical companies is desirable;
Knowledge of European regulations for clinical trials is desirable.