Leads Trial Master File (TMF) Operations activities for assigned studies and products in accordance with ICH, GCP, and regulatory requirements. Contributes to formulating and implementing global TMF and inspection readiness strategy. Influences clinical operations and CRO staff to achieve and maintain compliance with ICH, GCP, and regulatory requirements and guides best practices for real time inspection readiness. Implements a new eTMF platform for use by CRO and Sarepta staff, develops SOPs and tools supporting TMF compliance. Builds and maintains relationships within GRA, cross functionally, and with CRO counterparts to ensure effective communication and efficient development and implementation of TMF activities. Facilitates risk identification and mitigation strategies. Oversees activities of junior TMF personnel. Manages contractual and budgetary responsibilities with best business practices.
Primary Responsibilities Include:
May serve as the designee for the head TMF Operations and Inspection Readiness in activities related to TMF compliance and inspection readiness and at meetings with senior management as needed
Collaborates cross functionally and with CRO counterparts to implement a strategic and cohesive approach to TMF Operations and Inspection Readiness, the overall culture, and quality deliverables
Develops and implements processes and tools to enhance and support compliance for clinical trials and TMF
Provides oversight of TMF and Inspection Readiness (TMF Team) activities to meet the clinical trial and/or portfolio timelines
Advises on critical inspection risks, quality and compliance related issues, and corrective actions steps to mitigate inspection risks
Represents TMF Team in execution of regulatory inspection(s) and internal audits of TMF
Collaborates with Clinical Development and CQA to develop inspection preparation plan, and applicable tools, for programs/trials and provides oversight / tracking of activities
Represent TMF Team in CRO/vendor interactions/meetings related to TMF and inspection readiness deliverables as appropriate
Assists with optimizing the Standard Operating Procedures (SOPs), processes, training, and rollout across Clinical Development
Supervises TMF manager and specialists.
Oversees and, as needed, may perform archival of TMF documents, retrieval of archived records, tracking/monitoring, metrics and reporting, configuration updates, etc.
Assist Clinical Quality as needed with Site and CRO inspection preparation activities related to TMF and Global Regulatory Affairs
Impact and Scope:
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
Any mistake would have immediate impact to team Function and any direct reports and may have larger impacts to cross functional teams
The incumbent would be interacting with the team, Director level, and cross functional teams regularly, including external vendors
Works to facilitate individual and sub-team goal setting with direct reports
Education and Skills Requirements:
Expert knowledge of ICH, GCP, regulatory requirements, and clinical trial documents related to TMF
Experience with electronic document management systems, preferably experience with the Veeva eTMF system
Familiarity with the Trial Master File Reference model and a demonstrated understanding of records management best practices.
Experience in supporting Regulatory Authority (e.g. FDA, EMA, MHRA) GCP inspections is preferred
Ability to work in a dynamic environment and promote continuous improvement
Working knowledge of clinical trial management activities in an outsourced CRO model
Excellent communication skills, verbal, written and presenting in English as well as diplomacy, cross-cultural and team skills
BS with 10+ years of related experience
Prior experience with TMF and health authority
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.