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 Business Lead
Builds
Efficient and effective TMF processes and regulatory compliance frameworks
Domain
Life Sciences / Clinical Development Operations / eTMF
Required skills
Clinical development operations expertise, eTMF knowledge, Clinical business systems proficiency, Process documentation, Compliance auditing, User Acceptance Testing coordination, Cross-functional collaboration
Preferred skills
Project management methodologies, Vendor management
Technologies
Clinical business systems, eTMF platforms
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; Provide business and regulatory approvals; Participate in User Acceptance Testing; Create and maintain process documentation; Manage compliance activities including audits and inspection readiness; Troubleshoot system issues.
Seniority
Senior, hands-on IC with management responsibilities
