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 training programs for internal teams and external partners.
Domain
Clinical Trials / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
TMF Management, eTMF systems (Vault Clinical/Veeva), ALCOA+ standards, GCP, ICH guidelines, Process Optimization, Training & Coaching, Stakeholder Engagement, Audit & Inspection readiness, KPI monitoring
Preferred skills
Project management methodologies, Automation/Innovation implementation
Technologies
Vault Clinical, Veeva CTMS, eTMF
Responsibilities
Provide leadership within the TMF governance structure as Subject Matter Expert. Develop and maintain procedural documents, SOPs, and work instructions. Oversee compliance activities and implement process improvements. Lead training and coaching for TMF operations teams. Collaborate with stakeholders to ensure inspection readiness. Monitor TMF system performance and address technical gaps. Lead continuous improvement initiatives and participate in audits.
