Senior Manager, Records Management - Clinical Operations

This position is remote or, if in the Bay Area, in-house/hybrid and reports to the Head of Business Operations.

About the role

The Senior Manager, Records Management will lead activities to support major initiatives across the Records Management Organization. This role provides leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality. Beyond TMF responsibilities, the position oversees reporting, metrics, KPIs, and analytics that support performance measurement, delivery optimization, and continuous improvement. The Senior Manager will collaborate with Clinical Operations, other functional areas, CRO partners, and key stakeholders on TMF processes and systems.

Responsibilities

• Oversee and manage 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 in line with relevant regulations (e.g., ICH-GCP, EMA, MHRA) and industry best practices (e.g., CDISC Trial Master File Reference Model).
• Partner with subject-matter experts to modify and improve existing documents as required.
• Identify, recommend, develop, and lead operational excellence initiatives, including creating and delivering tools, processes, templates, training, onboarding, and guidance to drive efficiency, compliance, and best practices while ensuring quality.
• Manage resources to ensure appropriately skilled teams support the Records Management Organization, including hiring, training, mentoring, and assessing performance during bi-annual review periods.
• Support Records Management inspection-readiness activities.
• Create and generate reporting metrics, KPIs, and analytics to measure performance, compliance, and effectiveness.
• Lead interpretation of metrics and analytics to identify trends, risks, and opportunities.
• Participate in and support audits and inspections; respond to and assist with CAPA/process improvements.
• Serve as System Business Administrator for Veeva eTMF.
• Evaluate Veeva eTMF for system improvements, partnering with IT during system updates and User Acceptance Testing.
• Assist with requests supporting partner operationalized studies.
• Provide operational leadership for TMF vendor budget negotiations and management of TMF operations spend.
• Build collaborative relationships with key internal and external stakeholders.
• Serve as the TMF Operations functional area representative for implementing systems or processes that interface/integrate with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC).
• Lead governance committees with TMF vendors.

Requirements

• Bachelor’s degree, preferably in a scientific field.
• 8+ years of related industry experience at a Sponsor or CRO, plus 3+ years of Clinical TMF management (extensive experience with Veeva Vault and Veeva applications is strongly preferred).
• Previous experience supporting audits and regulatory inspections (e.g., FDA, PMDA, EMA, MHRA).
• Thorough understanding of ICH-GCP guidelines and regulatory requirements as they apply to the TMF.
• Extensive experience in oversight and management of vendors.
• Proficient in identifying, understanding, and mitigating risks while communicating them to clinical leadership.
• Strong leadership and project management abilities, with flexibility in a multi-functional, global matrix environment.
• Knowledge of industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model).
• Proficient in developing and writing SOPs.
• Understanding of clinical trial processes and experience driving execution.
• Ability to handle multiple projects simultaneously with strong attention to detail while understanding higher-level strategy.
• Excellent interpersonal, communication, and negotiation skills, both verbal and written (including presenting materials to internal teams and external partners).
• Self-motivated, able to work independently or as part of a team.
• Strong problem-solving and decision-making skills.
• Excellent Microsoft skills and experience using clinical trial management web-based systems (e.g., EDC, IRT, CTMS, eTMF).
• Ability and willingness to travel approximately 10%.

Pay

The anticipated salary range for fully qualified candidates is $155,000 - $170,000 USD annually. Actual salary may vary based on education, experience, tenure, skills, internal equity, and market alignment.

Benefits

In addition to a competitive market-based salary, Arcus offers participation in stock programs, a performance-based bonus, and a comprehensive benefits package. More information about total rewards can be found at https://arcusbio.com/careers.

Physical Requirements

• Primarily a sedentary office classification, though standing in work areas and walking between them may be required.
• Finger dexterity needed for computer use and operating standard office equipment.
• Occasional bending, stooping, kneeling, reaching, pushing, and pulling to retrieve and file information.
• Ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.