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Clinical Records Associate

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

This is a Clinical Records Associate role to be based in Stockley Park on a permanent basis.

Key Responsibilities:

  • Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation
  • Establish and implement procedures for clinical, non-clinical and bioanalytical records in accordance with record retention policy and record retention schedules
  • Oversee continued security and maintenance of the Trial Master File (TMF) Room
  • Manage development and implementation of procedures for the establishment, security, and maintenance of the Trial Master Files, preclinical study records and bioanalytical documentation
  • Participate in the development of Trial Master File SOPs
  • Create and implement training programs and tools for Gilead and contract employees responsible for filing of clinical trials records
  • Conduct training for Gilead and contract employees on the TMF SOPs
  • Audit compliance with clinical (TMF) procedures and training programs
  • Participate in preparation and follow-up of regulatory agency and internal GCP inspections
  • Manage vendor relationships including offsite storage
  • Create and maintain study specific file structures for Gilead clinical documentation and file documents accordingly
  • Ensure record filing is kept up to date and is performed accurately
  • Responsible for offsite archival and retrieval of clinical records (TMF) documents
  • Participate in periodic file room utilization reviews
  • File incoming documents and retrieve documentation from the TMF Room upon request
  • Ensure appropriate documentation completed to track archival of files
  • Participate in development of electronic tracking/ filing systems. Maintain both electronic and hardcopy department documentation

Knowledge, Experience and Skills:

  • Demonstrated effective verbal, written, interpersonal and presentation skills
  • Working knowledge and experience with MS Word, PowerPoint and Excel and advanced Adobe Acrobat
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
  • Previous experience of clinical records management experience in the pharmaceutical industry
  • Educated to degree level or equivalent in a relevant scientific discipline 
  • Travelling is essential part of this role and a valid passport is required

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)

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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