Director, Trial Master File (TMF) Process Lead
Posted on Apr 6, 2021 by Agios Pharmaceuticals
Agios Pharmaceuticals is seeking an experienced Director, Trial Master File (TMF) Process Lead to drive the vision and strategy of TMF management at Agios. This position would develop long range plans for TMF process optimization and resourcing. In addition, this position would work collaboratively with senior leadership and our CRO partners to ensure engagement and TMF compliance across the GDD portfolio in accordance with FDA, EMA, GCP, and ICH guidelines
Provide leadership for the eTMF records management fostering a collaborative cross-functional team culture while ensuring Agios study eTMFs are of the highest quality, audit & inspection ready and meet all applicable SOPs, regulations and guidelines
Acts as the clinical development operations eTMF process owner and SME by providing expertise, best practices related to the clinical records management, system implementation/modification and training development.
Assists with site/sponsor audits and regulatory inspections, assisting with in-house and site inspection readiness planning and training.
Identifies and/or anticipates eTMF risks and plans accordingly for mitigation and escalates issues to management as necessary.
Actively engages, communicates and collaborates with Agios functions and CRO stakeholders to ensure awareness of eTMF business processes, requirements, interpretation of metrics and to drive timely and high quality TMF management
Develop consistent TMF best practices/processes and develop master configuration manuals based on DIA reference model and Agios/CRO requirements
Creates and conducts eTMF training for internal Agios team, CROs and vendors
Provides input to CRO preferred partnership procedures for TMF quality standards on behalf of Agios, when required
Works closely with and oversees CRO partners to assess metrics, quality, and KPIs and implements corrective actions as necessary
Keeps line of sight to eTMF industry trends and regulatory requirements and continuously improves upon Agios eTMF processes and procedures as a result.
Supports identification and management any TMF CAPAs and/or TMF quality issues with input from management and GCP QA
Provides oversight and management of TMF team resources and TMF/records management vendor(s)
Provides mentorship to Clinical Trial Associates and TMF specialists as the department needs grows.
Bachelor's degree with a life science or healthcare focus or nursing degree required
5-10+ years' direct TMF/eTMF experience (sponsor experience required)
Management of TMF vendors as well as collaboratively worked with CROs/vendors and complex protocols
Proven experience in the TMF oversight across all stages of clinical studies, preferably in a global environment
Exhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalation to the program level or to Senior Management
A detailed understanding of overall strategic direction, interrelationships and business needs
Knowledge of ICH GCP, DIA Reference Model and knowledge of Medical Terminology strongly preferred
Ability to organize and manage multiple priorities required
Excellent oral and written communication skills required
Willingness to travel 10% of the time