Senior Manager, Records Management - Clinical Operations

The Senior Manager, Records Management will lead initiatives across the Records Management Organization, providing oversight of Trial Master File (TMF) operations to enhance functionality, efficiency, scalability, and quality. This role also oversees reporting, metrics, KPIs, and analytics to support performance measurement, delivery optimization, and continuous improvement. The position collaborates with Clinical Operations, other functional areas, CRO partners, and key stakeholders on TMF processes and systems. This role is remote or hybrid (if in the Bay Area) and reports to the Head of Business Operations.

Responsibilities

• Oversee and manage vendors supporting Arcus TMF and associated processes.
• Lead the development and oversee TMF-related standards, standard operating procedures (SOPs), and controlled documents aligned with 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 needed.
• Identify, recommend, develop, and lead operational excellence initiatives, including 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 reviews.
• Support Records Management inspection-readiness activities.
• Create and generate reporting metrics/KPIs and analytics to measure performance, compliance, and effectiveness.
• Interpret metrics and analytics to identify trends, risks, and opportunities, ensuring accuracy and actionable insights.
• 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 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 internal and external stakeholders.
• Serve as the TMF Operations functional representative for systems or processes interfacing 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 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 with strong attention to detail while aligning with higher-level strategy.
• Excellent interpersonal, communication, and negotiation skills (verbal and written), including presenting to internal teams and external partners.
• Self-motivated, able to work independently or as part of a team, with 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%.
• Role can be based at Hayward or Brisbane, CA (preferred) or fully remote.

Pay

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

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package. Additional information about total rewards can be found here.