GCP Compliance Operations Manager

San Francisco, CA | Clinical Operations

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Job Description

Job Summary:  Support the Clinical Development organization by contributing to the definition, implementation, and support of processes that build quality into clinical trial operations  

Role and Responsibilities:

The GCP Compliance Ops Manager works closely with the Director of GCP Compliance Operations, Clinical Teams, and Quality Assurance to manage and support a culture of quality, regulatory compliance, and continuous inspection readiness.

This position is responsible for fostering and promoting a GCP compliant environment with internal and external stakeholders. Manages aspects of continuous inspection readiness. In concert with the Director of GCP Compliance, serves as Clinical Operations department liaison with Quality Assurance.

 Responsibilities:

  • Manage aspects of GCP operational and compliance-related activities, as needed
  • Represent GCP Compliance Operations at project team and other meetings
  • Lead assigned projects related to process improvement and compliance monitoring
  • Interpret clinical trial regulations and guidelines, and provide guidance to stakeholders
  • Participate in developing and implementing inspection preparation strategies
  • Conduct ad-hoc site visits to assess and assist with inspection preparedness
  • Lead assigned continuous inspection readiness activities; e.g., Trial Master File review, managing TMF archive processes
  • Write and deliver presentations on GCP-related topics for investigator meetings and other events
  • Review clinical documents for compliance with regulations, regulatory guidelines, and SOPs
  • Provide input to inspection preparation strategies and activities
  • Recommend operational and compliance-related process improvements
  • Provide logistical support for Study Managers and CRAs for the clinical trial(s) which are likely to be audited
  • Participate in regulatory inspections as facilitator of back room processes activities; perform other inspection roles such as retrieval and review of documents, tracking of inspection requests, interpreting scribe notes
  • Advise on content of audit CAPA responses
  • Create and maintain tools (e.g., worksheets, trackers) to ensure successful completion of deliverables related to compliance, inspection readiness, and regulatory authority requests
  • Help prepare Clinical Operations Subject Matter Experts for interaction with FDA Field Investigators, business partners, and other inspectors/auditors
  • Work with CROs as needed to obtain study documents required for ongoing TMF maintenance and inspection purposes.As needed, confirm that essential study documents (generated by Clovis, CRO and study sites) are filed in their designated repositories

 

Skills & Requirements

Qualifications:

  • Advanced knowledge of ICH GCP guidelines and FDA Code of Federal Regulations for clinical research, experience with other international regulations preferred
  • Attention to detail and accuracy in work
  • Excellent verbal, written communication and interpersonal skills
  • Able to perform activities in a timely and accurate manner
  • Work according to procedures, rules and regulations
  • Critical thinker with ability to synthesize information from multiple sources and apply to problem-solving
  • Positive, self-starter, able to multi-task, and thrives under pressure
  • Able to work across multiple projects and prioritize tasks as required
  • Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint

Requirements/Education:

Previous background or experience (8-10 years) in clinical operations, quality assurance, clinical compliance, regulatory, or scientific/health care field is preferred.  Bachelor’s degree required.  An energetic, positive, flexible attitude and interest in professional growth is important. This is an office based position (San Francisco, CA) with some travel.