Electronic Trial Master File Specialist

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; additional requirements may apply.