Senior Manager, Records Management - Clinical Operations

Responsibilities:
- Lead oversight of Trial Master File (TMF) operations to improve functionality, efficiency, scalability, and quality.
- Oversee vendors supporting Arcus TMF and associated TMF processes.
- Develop and manage TMF standards, SOPs, and controlled documents aligned with regulations (e.g., ICH-GCP; EMA/MHRA) and industry best practices (e.g., CDISC TMF Reference Model).
- Drive operational excellence initiatives (tools, processes, templates, training, onboarding, guidance) integrating quality into all processes.
- Manage resources and team performance (hiring, training, mentoring, bi-annual performance reviews).
- Support records management inspection readiness; participate in audits/inspections and CAPA/process improvements.
- Create and interpret reporting metrics/KPIs and analytics; identify issues, risks, trends, and opportunities.
- Serve as System Business Administrator for Veeva eTMF; evaluate eTMF for improvements with IT and support UAT.
- Support partner operationalized studies; assess systems supporting TMF.
- Provide operational leadership for TMF vendor budget negotiations and TMF operations spend.
- Represent TMF Operations for interfaces/integrations (e.g., CTMS, EDMS, ISF, CDMS/EDC) and lead TMF vendor governance.

Qualifications:
- Bachelor’s degree (preferably scientific).
- 8+ years sponsor/CRO experience; 3+ years clinical TMF management required. Strongly preferred: Veeva Vault and Veeva applications.
- Experience supporting audits/regulatory inspections (FDA, PMDA, EMA, MHRA).
- Thorough understanding of ICH-GCP and TMF regulatory requirements.
- Extensive vendor oversight experience.
- Risk identification/mitigation with effective communication to clinical leadership.
- Strong leadership and project management in a global matrix environment.
- Familiarity with DIA Records Management Community (TMF Reference Model).
- Proficient in developing/writing SOPs.
- Understanding of clinical trial processes and driving execution.
- Ability to manage multiple projects; strong attention to detail.
- Excellent communication, interpersonal, and negotiation skills.
- Self-motivated; independent and team-oriented; strong problem-solving and decision-making.
- Excellent Microsoft skills; experience with EDC, IRT, CTMS, eTMF, etc.
- Travel ~10%.

Location/Compensation/Benefits:
- Role based in Hayward or Brisbane, CA (preferred) or remote.
- Salary range: $155,000–$170,000 USD annually; eligible for stock programs, performance-based bonus, and comprehensive benefits.