Manager, Clinical Records

Corcept Therapeutics • Redwood City, CA

17d

About The Position

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. 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 will play a critical part in supporting the integrity, inspection-readiness, and compliance of Trial Master Files (TMFs) across all phases of clinical development.

Requirements

• Strong knowledge of ICH-GCP, 21 CFR Part 11, and regulatory requirements related to clinical documentation
• Proven experience with eTMF systems (specifically Veeva Vault)
• Familiarity with clinical trial lifecycle and documentation requirements from start-up to close-out
• Excellent communication, organizational, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment with attention to detail
• Bachelor’s degree in Life Sciences, Health Information Management, or related field
• 5+ years’ experience in clinical records or document management within a biotech, pharmaceutical, or CRO environment

Nice To Haves

• Experience leading projects or mentoring junior staff preferred
• Experience with paper TMF and certified copy is a plus
• Master’s preferred

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees