Job Title: Electronic Trial Master File Specialist
Job Number: 28852
Location: Cambridge, MA
Reporting to the Clinical Operations Leader, 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. The Gates MRI offers flexible work arrangements for local candidates for this role located on site in our Cambridge, MA HQ.
Essential Duties And Responsibilities Include
- 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
- Minimum B.A./B.S. degree in science/healthcare field required
- 2+ years of relevant clinical research and TMF experience at a biotechnology, pharmaceutical company or CRO required
- Previous experience working in eTMF system software; experience in Veeva Vault eTMF system software preferred.
- Solid understanding of the clinical trial process. Experience in 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
- Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP), Good Documentation Practices, and International Council for Harmonization (ICH) E6(R2) guidelines
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast- paced environment
- Strong organization skills with outstanding attention to detail and follow through
- Demonstrated effective communication skills to internal and external team members
- Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities while exhibiting the highest level of customer service
- Demonstrated proactive approaches to problem-solving with strong decision-making capabilities
- Must be fully proficient in MS Office Suite, and conversant with Smartsheets and SharePoint.
- Demonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission
As part of our standard hiring process for new employees, employment with the Bill & Melinda Gates Medical Research Institute will be contingent upon successful completion of a background check.