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Senior Clinical Trial Manager Associate - Oncology

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 Gilead’s products. For the team based in our European Headquarters in Uxbridge, we are looking for a Senior Clinical Trial Manager Associate to work within the Oncology therapy area.

Senior Clinical Trial Manager Associate duties include:

  • Must meet all requirements for Clinical Trial Management Associate position and have demonstrated proficiency in all relevant areas;
  • Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs;
  • 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;
  • May be asked to assist in the training of Clinical Trial Management Associates and Clinical Project Assistants;
  • 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 up to 20-30%.

Knowledge, Experience and Skills:

  • Typically requires a BSc or BA in a relevant scientific discipline or RN qualification;
  • Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent;
  • CRA experience preferred;
  • Oncology experience preferred but not essential;
  • Excellent verbal, written, interpersonal and presentation skills are required;
  • Must be familiar with routine medical/scientific terminology;
  • Must be familiar 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 initiatives under general supervision as required.

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