TMF Operations Manager

Role Overview

• Responsible for the strategic oversight, operational management, and continuous improvement of the Trial Master File (TMF) across clinical studies from eTMF build to archival, including development of TMF Plan, Index, distribution of metrics, escalation of issues, user access management
• Lead TMF quality review activities, including ongoing completeness checks ensuring that all required documents are accurately filed, complete, and accessible
• Liaison to the CRO TMF team, responsible for ongoing review of reported KPIs and reports providing expert guidance and support on TMF documentation requirements and timely escalation and mitigation strategies to Sponsor management throughout the study lifecycle
• Identify eTMF trends and commonly misfiled documents, and lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps, including implementing corrective actions to prevent future issues
• Lead the creation and delivery of targeted training sessions for the study team including guiding key document attributes (i.e., classification of documents) and resolution of document queries
• Collaborate with entire study team to gather and provide critical information needed for the execution of the expected document list and expected numbers, ensuring alignment with study specific TMF Plan/Index; serves as the Subject Matter Expert (SME) for TMF documents for the entire study team, inclusive of vendors
• Provide regular TMF status updates during internal and external study team meetings
• Prepare for and support audits related to the TMF, including preparation of documentation, supporting audit activities and leading resolution of audit findings
• Supports the development and review of standard operating procedures (SOP) and work instructions (WI) related to clinical document management, as appropriate
• Participate in inspection readiness activities, including supporting the development of study Storyboards, FDA BIMO preparation, MHRA dossier preparation, etc.

Requirements

• Bachelor's degree or equivalent combination of education and experience in science or health related field
• Minimum 5 years of clinical operations experience, at least experience, including global trial experience
• Thorough knowledge of the CDISC TMF Reference Model, ALCOA+ standards, Good Documentation Practices, and FDA/EMA/MHRA regulations
• Experience with eTMF systems (eg, Medidata RCM, Trial Interactive) that includes but not limited to development of training materials, SOPs, performing UATs and change control management
• Ability to independently engage in cross-functional interactions with internal and external staff
• General knowledge of clinical trials and basic principles of overall trial planning and execution
• Prior participation in regulatory health inspections (eg, FDA, EMA, MHRA) is preferred
• TMF SME experience in inspection preparation activities, including mock inspections
• Experience balancing CRO TMF SOP requirements and internal expectations that require a dedication to rigorous quality standards
• Technical experience creating data visualizations, data summaries, and project management tools in MS Excel, Smartsheet is preferred

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and vesting after the turn of the first month after your start date
• Flexible time off
• Generous parental leave and some fun fringe perks!