Contract - eTMF Specialist

San Francisco, CA, United States
Mar 30, 2021
Biotech Bay
Required Education
Position Type
Full time
CONTRACT - eTMF Specialist

Position Summary:

This position will provide subject matter expertise and Clinical Operations Team support required to ensure that the Electronic Trial Master File (eTMF) is audit and inspection ready for an ongoing GBT trials. Ensuring the eTMF is managed in accordance with relevant regulations, ICH-GCP guidelines and GBT SOPs. Contributes to the develop of SOPs, Work Instructions (WIs) and other tools to ensure compliance with applicable regulations and Global Blood Therapeutics' records retention policies and practices. Train Clinical Trial Associates (CTAs) and other team members on eTMF system and processes. Work cross-functionally with internal departments and external resources to resolve gaps in the eTMF.

Essential Duties and Responsibilities:

  • Act as the single-point-of-contact at GBT for all eTMFs
  • Serve as subject matter expert on domestic/international documentation requirements
  • Maintenance and management of overall eTMF operations including coding and filing of all study documents per DIA model structure
  • Assist in developing eTMF-related SOPs, working practices, and forms, as needed, to ensure compliance with ICH E6(R2)
  • Ensure document quality and compliance through active engagement with clinical study teams and management
  • Identify opportunities for continuous process improvement; recommend solutions.
  • Participate in eTMF vendor search and selection
  • Contribute to the specification, configuration, migration, UAT and implementation of the eTMF solution
  • Evaluate study requirements; ensure appropriate eTMF structure is developed prior to start-up
  • Support training of Clinical Development personnel on the eTMF solution and relevant SOPs
  • Ensure Clinical Development personnel are appropriately assigned eTMF User roles and permissions
  • Ensure the eTMF is maintained with an audit-ready strategy
  • Create and distribute eTMF status updates to GBT Clinical Trial Managers and CRAs for CRO follow-up and resolution
  • Ensure identified discrepancies noted in status reports are addressed and resolved within timelines designated in TMF plan
  • Coordinate interim, and close-out eTMF audits with Clinical QA
  • Participate in audits and/or inspections of Clinical Operations and the eTMF
  • Perform other tasks and assignments as needed and specified by management
  • Accompany Clinical QA on site audits as appropriate


  • Proficiency with eTMF technology including prior, demonstrated experience managing eTMF systems and/or service providers is required
  • Experience with Veeva Vault eTMF software is highly desirable
  • Associates/Bachelor's degree in a relevant discipline preferred
  • Up to 2 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment in roles focused clinical trial documentation
  • Experience with the Drug Information Association (DIA) Trial Master File Reference model and a demonstrated understanding of records management best practices
  • Demonstrated understanding of the clinical drug development process and clinical trial methodology
  • Demonstrated current knowledge of ICH, GCP and other regulatory guidance as applicable to management of clinical documentation
  • Demonstrated ability to assess current and future business needs to ensure the clinical documentation function is strategically and operationally positioned to properly support the Clinical Operations, Regulatory Affairs and Clinical QA
  • Demonstrated leadership ability
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
  • Able to attend off-site meetings/training/conferences as needed
  • Experience leading and/or contributing to the selection and/or implementation of an electronic eTMF
  • Knowledge of ICH-GCP guidelines in relation to TMFs