Sr. Manager, TMF Process Lead
Core
Lead TMF governance, process optimization, and quality oversight for clinical studies, ensuring inspection readiness and regulatory compliance.
Role type
Senior Manager, TMF Process Lead
Builds
Optimized TMF processes, procedural documentation, and inspection-ready clinical study archives
Domain
Clinical trials / Regulatory compliance / eTMF operations
Required skills
TMF governance, process optimization, SOP development, training & coaching, stakeholder engagement, system technical oversight, audit leadership, KPI monitoring, ALCOA+ standards, GCP, ICH guidelines
Preferred skills
Project management methodologies, automation innovation
Technologies
Vault Clinical, Veeva CTMS, eTMF
Responsibilities
Provide leadership within TMF governance structure; Develop training materials and coach eTMF Operations Analysts; Create and maintain SOPs and work instructions; Oversee compliance activities and CRO TMF transfers; Implement technical enhancements to eTMF systems; Lead continuous improvement initiatives and participate in TMF audits
Seniority
Senior, hands-on IC with management responsibilities
