Senior Manager, Records Management - Clinical Operations

Responsibilities:
- Oversee and manage vendors supporting Arcus TMF and associated processes.
- Develop and oversee TMF-related 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) to improve efficiency, compliance, and quality.
- Manage resources and ensure appropriately skilled teams; participate in hiring, training, mentoring, and bi-annual performance reviews.
- Support records management inspection-readiness activities.
- Create and generate reporting metrics/KPIs and analytics to measure performance and compliance.
- Interpret metrics/analytics to identify issues, trends, risks, and opportunities.
- Participate in audits/inspections; support CAPA and process improvements.
- Serve as System Business Administrator for Veeva eTMF; evaluate for system improvements and partner with IT on updates and UAT.
- Support partner operationalized studies; drive ongoing assessment of systems supporting TMF.
- Lead TMF vendor budget negotiations and manage TMF operations spend.
- Represent TMF Operations for system/process implementations interfacing with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC).
- Lead governance committee with TMF vendors.

Qualifications:
- Bachelor’s degree (preferably scientific).
- 8+ years sponsor/CRO industry experience; 3+ years Clinical TMF management (Veeva Vault/Veeva applications strongly preferred).
- Experience supporting audits and regulatory inspections (FDA, PMDA, EMA, MHRA).
- Strong understanding of ICH-GCP and TMF regulatory requirements.
- Extensive vendor oversight/management experience.
- Risk identification/mitigation and communication skills.
- Leadership/project management in global matrix environments.
- Knowledge of TMF industry workgroups (e.g., DIA TMF Reference Model).
- Proficient in SOP development/writing.
- Understanding of clinical trial processes and driving execution.
- Ability to manage multiple projects; strong attention to detail.
- Excellent interpersonal, negotiation, and communication skills.
- Strong Microsoft skills; experience with clinical trial systems (EDC, IRT, CTMS, eTMF, etc.).
- Travel ~10%.

Location: Hayward or Brisbane, CA (preferred) or remote.