eTMF Specialist

The eTMF Specialist is responsible for assisting with the operational strategy for the eTMF process, ensuring quality trial master file documents are being collected and filed in compliance with ICH/GCP guidelines, and delegated by trial sponsors. The TMF operational team works with departmental functional leads to support inspection readiness as a culture and compliance with GCP regulatory requirements.

Essential Duties and Responsibilities

• Supports the set-up, maintenance, and archival of study Trial Master Files

• Acts as point person for receipt of documents to be submitted into the study-specific eTMF from the sites, sponsor and/or CRAs

• Conducts initial reviews of documentation upon receipt to ensure alignment with ALCOA+ standards

• Submits documentation into the respective study-specific eTMFs and assigns document metadata such as site number and expiration dates, as applicable

• Ensures that documents that fail TMF review are effectively remediated and follow-up is provided to eTMF Specialist/Manager

• Maintains eTMF trackersand delivers these materials to project management personnel, as needed

• Ensures effective communication and issue escalation across TMF stakeholders

• Collaborates cross-functionally to create and/or update plans, training materials and procedural documents, as applicable

• Attends internal CTA meetings

• Assists in the development of the structure of TMF and filing system and is responsible for filing and maintaining up to date study documents

• Performs periodic regulatory document QC and reconciliation activities, to ensure inspection readiness and regulatory compliance

• Files study documents into the TMF in accordance with standard operating and clinical procedures.

• Assists with internal and external TMF audits

• Reviews TMF documentation once filed in the TMF and remediate any issues directly with the functional team. Track resolution/closure via tracking mechanisms and uploads to the TMF

• Performs a close out review of study TMF and remediate findings with the study lead and/or external vendors, in preparation for the TMF study closure

• May provide support to the clinical trial manager(s) with all phases of study conduct (feasibility, start-up, maintenance and close out) of clinical trials

• Updates Expected Document Lists as appropriate throughout life of study

• Performs other activities as assigned

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

• Minimum 3 years’ experience in clinical research industry related to document management/TMF; or equivalent and relevant training and experience

• Demonstrated experience working with TMF technologies and/or document management applications

• eRegulatory system experience

• Ability to work effectively independently with minimal supervision

• Advanced knowledge of TMF Reference Model and ALCOA+ standard country regulations

• Thorough knowledge of regulatory requirements for clinical trials (ICH/GCP)

• Excellent planning, coordination and time management skills to meet deadlines

• Attention to detail

• Strong computer proficiency in Microsoft Word, Excel, and Outlook

• Mentors less experienced TMF employees

• Ability to travel up to <10%