Manager, Clinical Records

Role Summary

We are seeking a detail-oriented, proactive, and highly organized Manager of Clinical Records to oversee the collection, organization, maintenance, and archiving of clinical trial documentation in accordance with GxP standards, ICH-GCP guidelines, and applicable regulatory requirements. This role supports the integrity, inspection-readiness, and compliance of Trial Master Files (TMFs) across all phases of clinical development.

Responsibilities

• Work with Head of Clinical Records, clinical service providers, and study teams to provide oversight and maintenance of the Trial Master File (TMF), both electronic (eTMF) and paper-based, ensuring alignment with company SOPs, industry best practices, and regulatory standards
• Collaborate cross-functionally with all Corcept functional areas (e.g., Clinical Operations, Regulatory Affairs, Quality, Data Management) and CRO partners to ensure timely and accurate documentation of clinical activities
• Coordinate and conduct routine QC reviews of TMF content to ensure completeness, accuracy, and inspection readiness
• Train and mentor clinical staff and Service Provider partners on TMF processes, document standards, and expectations
• Support the development and revision of SOPs and work instructions related to TMF management and clinical documentation
• Monitor and report TMF metrics and KPIs to leadership
• Implement process improvements to enhance TMF quality, compliance, and efficiency
• Act as an additional point of contact during audits and inspections regarding clinical records and documentation

Qualifications

• Preferred: Strong knowledge of ICH-GCP, 21 CFR Part 11, and regulatory requirements related to clinical documentation
• Preferred: Proven experience with eTMF systems (specifically Veeva Vault)
• Preferred: Familiarity with clinical trial lifecycle and documentation requirements from start-up to close-out
• Preferred: Excellent communication, organizational, and problem-solving skills
• Preferred: Ability to manage multiple priorities in a fast-paced environment with attention to detail
• Preferred: Experience leading projects or mentoring junior staff
• Preferred: Experience with paper TMF and certified copy

Education

• Preferred: Bachelor’s degree in Life Sciences, Health Information Management, or related field (master’s preferred)
• Preferred: 5+ years’ experience in clinical records or document management within a biotech, pharmaceutical, or CRO environment