Senior Manager, Records Management - Clinical Operations

Responsibilities:
- Oversee and manage TMF vendor support and associated Trial Master File (TMF) processes.
- Lead development and oversight of 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, and guidance) to improve efficiency, compliance, and quality integration.
- Manage resources and ensure appropriate staffing, including hiring, training, mentoring, and bi-annual performance assessments.
- Support records management inspection readiness.
- Create and generate reporting metrics/KPIs and analytics to measure performance, compliance, and effectiveness.
- Interpret metrics/analytics to identify trends, risks, issues, and improvement opportunities.
- Support audits and inspections; assist with CAPA and process improvements.
- Serve as System Business Administrator for Veeva eTMF; evaluate and implement system improvements with IT (including UAT).
- Support partner operationalized studies.
- Lead ongoing assessment of systems supporting TMF.
- Provide operational leadership for TMF vendor budget negotiations and TMF operations spend.
- Represent TMF Operations in implementations integrating with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC).
- Lead governance committee with TMF vendors.

Qualifications:
- Bachelor’s degree (preferably scientific).
- 8+ years industry experience at Sponsor or CRO, plus 3+ years Clinical TMF management (extensive Veeva Vault/eTMF experience strongly preferred).
- Experience with audits and regulatory inspections (e.g., FDA, PMDA, EMA, MHRA).
- Deep understanding of ICH-GCP and TMF regulatory requirements.
- Extensive vendor oversight/management experience.
- Risk identification, mitigation, and communication to clinical leadership.
- Strong leadership and project management in global matrix environments.
- Knowledge of DIA Records Management Community / TMF Reference Model.
- Proficient in developing and writing SOPs.
- Understanding of clinical trial processes; ability to drive execution.
- Strong multitasking, attention to detail, and strategic thinking.
- Excellent communication (verbal/written), interpersonal, and negotiation skills.
- Self-motivated; capable of independent and team work; strong problem-solving/decision-making.
- Excellent Microsoft skills; experience with web-based clinical systems (EDC, IRT, CTMS, eTMF, etc.).
- Ability/willingness to travel ~10%.

Benefits:
- Stock programs, performance-based bonus, and comprehensive benefits package (plus salary range: $155,000–$170,000 USD annually).

Location/Work:
- Hayward or Brisbane, CA (preferred) or remote; may be in-house/hybrid and reports to Head of Business Operations.