Document/TMF Specialist

Our client in the greater Boston area is looking to add a eTMF/ Document Specialist to their team for the next year. In this role, you will support the clinical operations team by; ensuring that the Electronic Trial Master File (eTMF) is audit and inspection ready, is managed in accordance with relevant regulations/ICH-GCP guidelines and by helping to develop SOPs/Work Instructions (WIs). Ideal candidates will have current knowledge of ICH, GCP guidelines as it relates to the management of clinical documentation, along with prior experience leading or contributing to the selection and/or implementation of an electronic eTMF.

Qualifications:

• Experience with Veeva Vault eTMF software is a must
• Proficiency with eTMF technology including prior, demonstrated experience managing eTMF systems and/or service providers is required
• 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 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

Essential Duties and Responsibilities:

• Act as the single-point-of-contact 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 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

Job Type: Contract

Benefits:

• 401(k)
• Dental insurance
• Disability insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Veeva Vault eTMF software: 3 years (Preferred)
• managing eTMF systems: 3 years (Preferred)
• clinical trial documentation management: 2 years (Preferred)
• DIA TMF reference model: 2 years (Preferred)

Work Location: Remote