Contract - eTMF Operations Senior Manager

San Francisco, CA, United States
Nov 05, 2020
Biotech Bay
Required Education
Associate Degree
Position Type
Full time

Job Summary:
  • This position will provide subject matter expertise, oversight 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
  • Develop and lead a team responsible for management of inspection-ready Clinical Trial essential documents in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and GBT SOPs.
  • Lead and contribute to the development of SOPs, Work Instructions (WIs) and other tools to ensure compliance with applicable regulations and Global Blood Therapeutics' records retention policies and practices
  • Training of eTMF Specialists, Clinical Trial Associates (CTAs) and other team members on eTMF system and processes.
  • Identification of project risks, escalation and issue resolution related to eTMF
  • Develops and maintains eTMF activity-related timelines
  • Oversight of eTMF Specialists and identification of resources to successfully support eTMF operations
  • Work cross-functionally with internal departments and external resources to resolve gaps in the eTMF

Essential Duties and Responsibilities:
  • Accountable for the timely preparedness of eTMFs, approval of eTMF Management Plans, and maintaining routine oversight schedules to ensure archival and accessibility of all essential documents
  • Oversight of eTMF team responsible for ensuring accurate coding and filing of all essential study documents per DIA Reference model structure, SOPs and ICH GCP
  • Ensure establishment of SOP compliant study Trial Master File Plans
  • Ensure Clinical Trial Master Files are maintained with an inspection-ready strategy
  • Oversee implementation and management of eTMF applications
  • Oversee training of eTMF team along with training for internal or external eTMF users
  • Development and management of TMF vendor contracts and budgets
  • Oversight of eTMF vendors including regular phone and face-to-face meetings
  • Development and revisions of eTMF SOPs, work instructions and processes and forms, as needed, for continuous process improvement and to ensure compliance with ICH GCP
  • Ensure quality checks are performed as per SOPs and monitor staff progress in resolution of identified eTMF discrepancies
  • Serve as subject matter expert on domestic/international documentation requirements Establish and oversee eTMF Key Performance Indicator metrics and corrective actions when needed
  • Ensure routine distribution of eTMF status updates to Clinical Operations team and CRO follow-up and resolution
  • Represent the clinical document management function both internally and externally, when applicable
  • Oversight of eTMF migrations, transfers and file-location mapping documentation to/from CROs and partners, as applicable
  • Work in collaboration with all applicable functional areas and external resources to resolve gaps in the eTMF
  • Ensure document quality and compliance through active engagement with clinical study teams and management
  • Participate as an SME during audits / inspections of Clinical Operations and the eTMF and interact with auditor/inspector to address queries
  • Assist Clinical QA in site audit preparedness or performance
  • Perform other tasks and assignments as needed and specified by management

  • Proficiency with eTMF technology and applications including prior, demonstrated experience managing eTMF systems and/or service providers is required
  • Thorough knowledge of all sections of the DIA Reference Model (current version) documents from various functional areas and their appropriate eTMF filing requirements and a demonstrated understanding of records management best practices
  • Experience with Veeva Vault eTMF software is highly desirable
  • 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
  • Associates/Bachelor's degree in a relevant discipline preferred
  • Minimum of 10 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment in roles focused clinical trial documentation
  • Experience supporting regulatory submissions and inspections preferred
  • Thorough working knowledge of personal computer systems and desktop office applications, including proficiency in MS Word, Excel, and PowerPoint and Microsoft Project
  • Experience with people management experience with demonstrated experience in motivating teams, setting up goals, providing leadership and guidance as needed
  • Veeva certification a plus
  • Knowledge and experience with CTMS a plus