Sr. Manager, TMF System Business Lead
Core
Subject matter expert in clinical business systems supporting TMF (Trial Master File) processes, ensuring systems fit for purpose and regulatory compliance.
Role type
Senior Manager, Clinical Business Systems Lead (TMF)
Builds
Efficient and effective TMF processes and regulatory compliance frameworks
Domain
Life Sciences / Clinical Development Operations / Regulatory Compliance
Required skills
TMF process expertise, clinical business systems knowledge, process documentation, compliance auditing, stakeholder alignment, UAT coordination, system troubleshooting
Preferred skills
Project management methodologies, matrixed organization experience, complex issue resolution
Technologies
Clinical business systems, eTMF platforms, project management tools
Responsibilities
Provide subject matter expertise in clinical business systems for TMF compliance; Align with process owners on system utilization; Represent end-user needs to R&D IT for strategy and implementation; Collaborate with cross-functional teams and vendors for efficient TMF processes; Provide business and regulatory approvals per SOPs; Participate in User Acceptance Testing; Create and maintain process documentation; Serve as point of contact for compliance activities (auditing, inspection readiness); Collaborate with R&D IT for super user management and troubleshooting
Seniority
Senior Manager, hands-on IC with strategic alignment
