Corcept Therapeutics
Manager, Clinical Records
Corcept Therapeutics, Redwood City, California, United States, 94061
About Corcept
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.
Manager of Clinical Records 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.
Responsibilities
Work with Head of Clinical Records, clinical service providers, and study teams to provide oversight and maintenance of the 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
Preferred Skills, Qualifications and Technical Proficiencies
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
Experience leading projects or mentoring junior staff preferred
Experience with paper TMF and certified copy is a plus
Preferred Education and Experience
Bachelor’s degree in Life Sciences, Health Information Management, or related field (master’s preferred)
5+ years’ experience in clinical records or document management within a biotech, pharmaceutical, or CRO environment
The pay range that the Company reasonably expects to pay for this headquarters-based position is $156,600–$184,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job‑related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full‑time basis.
Corcept is an Equal Opportunity Employer
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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.
Manager of Clinical Records 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.
Responsibilities
Work with Head of Clinical Records, clinical service providers, and study teams to provide oversight and maintenance of the 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
Preferred Skills, Qualifications and Technical Proficiencies
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
Experience leading projects or mentoring junior staff preferred
Experience with paper TMF and certified copy is a plus
Preferred Education and Experience
Bachelor’s degree in Life Sciences, Health Information Management, or related field (master’s preferred)
5+ years’ experience in clinical records or document management within a biotech, pharmaceutical, or CRO environment
The pay range that the Company reasonably expects to pay for this headquarters-based position is $156,600–$184,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job‑related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full‑time basis.
Corcept is an Equal Opportunity Employer
#J-18808-Ljbffr