Senior Manager, Records Management - Clinical Operations
$155,000–$170,000 year
HybridHayward, California, United States or Brisbane, California, United States
Job Summary
Oversee Trial Master File (TMF) operations, vendor management, and operational excellence initiatives to enhance functionality, efficiency, and compliance with ICH-GCP and regulatory standards. Lead the development of standards, SOPs, and controlled documents while managing resources, including hiring, training, and performance reviews. Generate and interpret reporting metrics, KPIs, and analytics to measure performance and drive continuous improvement. Support inspection-readiness activities, audits, and CAPA process improvements, serving as System Business Administrator for Veeva eTMF. Collaborate with Clinical Operations, CRO partners, and stakeholders on TMF processes, system integrations, and budget negotiations. This role may be remote or in-house/hybrid in the Bay Area, reporting to the Head of Business Operations.
Required Qualifications
- Bachelor's degree
- 8+ years of related industry experience at a Sponsor or CRO
- 3+ years of Clinical TMF management
- 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
- Ability and willingness to travel approximately 10%
- Must possess mobility to work in a standard office setting and use standard office equipment, including a computer
- Vision to read printed materials and a computer screen
- Hearing and speech to communicate in person, before groups, and over the telephone
- Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment
- Ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds
Desired Qualifications
- preferably in a scientific field
- extensive experience with Veeva Vault and Veeva applications
- Demonstrates strong leadership and project management abilities, with flexibility and agility in a multi-functional, global matrix environment
- Knowledge and familiarity with 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 in driving execution
- Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy
- Excellent interpersonal communication and negotiation skills
- Strong communication skills, both verbal and written, are required (including presentation of materials to internal teams and external partners)
- Self-motivated and able to work independently or as part of a team
- Demonstrates problem solving and decision-making skills
- Excellent Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.)
- This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based
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