Senior Manager, Records Management

Job description

Summary The Senior Manager , Records Management ( S MRM) , will be responsible for leading activities to support major initiatives across the Records Management Organization. The ( S MRM) will provide leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalab ility, and quality. Beyond TMF responsibilities, this position oversees reporting , metr ics, KPIs, and analytics that support performance measurement, delivery optimization and continuous improvement. The SMRM will collaborate with the Clinical Operations department , other functional areas , CRO partners, and key stakeholders on TMF processes and systems. This position is remote or if in bay area in-house/hybrid, depending on prior experience . They will report to the head of Business Operations . Responsibilities: - Responsible for over sight and management of vendor s supporting Arcus TMF and associated processes for the TMF - Lead the d evelop ment and oversee TMF-related standards, standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and indus...