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 Systems & TMF Process Lead
Builds
Efficient and effective TMF processes and regulatory compliance frameworks
Domain
Life Sciences / Clinical Development Operations / Regulatory Compliance
Required skills
Clinical business systems expertise, TMF process knowledge, Regulatory compliance, Process documentation, Stakeholder alignment, User Acceptance Testing coordination, Cross-functional collaboration, Issue resolution
Preferred skills
Project management methodologies, Matrixed organization experience
Technologies
Clinical business systems, 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; 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.
