Position Summary
The Electronic Trial Master File Specialist (eTMF Specialist)
is responsible for the day-to-day management of eTMF, including oversight of the review and approval of eTMF documents and generation of reports to measure completeness, accuracy, and timeliness of the eTMF. This role has a strong focus on ensuring that document management operations are performed with adherence to ICH-GCP guidelines, other regulatory requirements, and standard operating procedures (SOPs). The role will also ensure the eTMFs for clinical studies are inspection ready at all times.
Primary Responsibilities
- Lead the development of the study specific eTMF plans for assigned clinical studies.
- Perform quality control of documents submitted to the eTMF using the established acceptable criteria
- Ensure clinical trial documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs
- Address eTMF questions pertaining to how documents are filed, and user questions related to the eTMF system
- Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed
- Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
- Monitor and identify study-specific eTMF trends and communicate to Clinical Operations and/ or other functional teams as needed
- Assist with inspection/audit related activities (e.g., preparation, correction action plans)
- Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirements
- Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
- 3+ years of relevant clinical research and eTMF experience at a biotechnology, pharmaceutical company or CRO required.
- Previous experience working in eTMF system software.
Professional Work Experience
- Solid understanding of the clinical trial process. Experience handling clinical trial related documents required and knowledge of Trial Master File Reference Model Structure standard.
- Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
- Must be fully proficient in MS Office Suite, and ideally conversant with Smartsheets and SharePoint.
- Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Other Essentials and Key Success Factors
- Successful track record of working in high-growth and dynamic organizations
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values and ethical standards
Travel
This position requires no regular travel.
The description and requirements outlined above are general; additionalrequirements may apply.
