Senior Manager, Records Management

The Senior Manager, Records Management (SMRM) will lead activities to support major initiatives across the Records Management Organization, providing leadership and oversight of Trial Master File (TMF) operations, reporting, metrics, KPIs, and analytics. This position will collaborate with the Clinical Operations department, CRO partners, and key stakeholders on TMF processes and systems.

Requirements

• Responsible for oversight and management of vendors supporting Arcus TMF and associated processes for the TMF
• Lead the development and oversee TMF-related standards, standard operating procedures (SOPs) and corresponding controlled documents
• Identify, provide recommendations, develop, and lead operational excellence initiatives
• Effectively manage resources to ensure appropriately skilled team are assigned to support Records Management Organization
• Support Records Management inspection-readiness activities
• Create and generate reporting metrics/ KPIs and other analytics
• Lead interpretation of metrics and analytics to ensure accuracy, interpretation and trends while identifying potential issues, trends, risks, and opportunities
• Participate and support in audits and inspections
• Serve as System Business Administrator for Veeva eTMF
• Evaluate Veeva eTMF for system improvements
• Assist with requests in support of partner operationalized studies
• Drive ongoing assessment of systems that support
• Provide operational leadership to TMF vendor budget negotiations and management of TMF operations spend
• Build collaborative relationships with key internal and external stakeholders
• Serve as TMF Operations functional area representative for the implementation of any systems or processes that would interface/integrate with TMF
• Lead governance committee with TMF Vendors

Benefits

• Performance-based bonus
• Comprehensive benefits package
• Stock programs