Manager, Clinical Records at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

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
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

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

Skills

Trial Master File (TMF)

eTMF

GxP

ICH-GCP

SOPs

QC reviews

Clinical Operations

Regulatory Affairs

Quality Assurance

Data Management

CRO management

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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