Corcept Therapeutics
Clinical Records Manager
Corcept Therapeutics, Redwood City, California, United States, 94061
Overview
Corcept is leading the way in the research and development of cortisol modulators. The organization has discovered more than 1,000 selective proprietary cortisol modulators and has a history including the FDA approval of Korlym (mifepristone) for hypercortisolism. Today, Corcept advances cortisol modulation across multiple disease areas and ongoing studies in endocrinology, oncology, metabolism, and neurology. The Associate Director, Clinical Records will provide strategic leadership and oversight for Corcepts Trial Master File (TMF) management processes across all clinical programs. This role is responsible for governance, quality, compliance, and inspection readiness of clinical documentation from study start-up through final archival. As a subject matter expert in eTMF operations and Veeva Vault, the Associate Director will drive innovation, ensure consistency across programs, and partner cross-functionally to support inspection readiness and regulatory compliance. This role requires a proactive and collaborative leader with a strong command of global TMF best practices, system optimization, and strategic planning within a GCP-regulated environment. Pay and Benefits
are as described in the job posting: see base pay range below and company information within this notice. Responsibilities
Provide strategic oversight and governance by leading the development and continuous improvement of TMF strategies, standards and procedures across all clinical programs Define and execute the long-term vision for clinical records and eTMF infrastructure, including risk mitigation, scalability and compliance Provide leadership and cross-functional collaboration by serving as the enterprise-wide TMF subject matter expert, offering guidance to clinical study teams, Quality Assurance and Regulatory Affairs Act as the primary TMF liaison during audits and inspections, ensuring readiness and addressing findings through corrective actions and continuous process improvement Collaborate with study teams to proactively manage TMF quality, regulatory compliance and inspection preparedness Establish and monitor KPIs and metrics to ensure ongoing TMF completeness, accuracy and timeliness; escalate risks and drive resolution Implement quality control measures, periodic reviews and oversight mechanisms to ensure compliance with global and local regulatory requirements Provide Veeva Vault oversight and system optimization by leading the configuration and lifecycle management of Corcepts Veeva Vault eTMF system Oversee vendor and license management, user training, validation activities and system upgrades in partnership with IT and QA Develop and maintain TMF-related SOPs, policies and work instructions aligned with ICH-GCP, the DIA Reference Model and evolving regulatory expectations Design and deliver training programs to internal staff and external partners to ensure alignment with Corcepts TMF processes and standards Identify and implement process enhancements and technology solutions to streamline document workflows and support clinical development goals Stay current with industry trends and regulatory developments to evolve Corcepts TMF strategies and ensure continuous inspection readiness Preferred Skills, Qualifications and Technical Proficiencies Deep expertise in Veeva Vault eTMF, including configuration, reporting and system administration Strong knowledge of DIA Reference Model, ICH-GCP and global regulatory requirements for clinical documentation Demonstrated success in leading cross-functional initiatives, driving compliance and supporting regulatory inspections Excellent skills in project management, stakeholder engagement and process improvement Strategic thinker with strong analytical skills and a collaborative leadership style Preferred Education and Experience 8+ years of experience in clinical records management with at least 3 years in a leadership or strategic role "The pay range that the Company reasonably expects to pay for this headquarters-based position is $185,000 - $205,600; 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. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept. Seniority level
Director Employment type
Full-time Job function
Health Care Provider
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Corcept is leading the way in the research and development of cortisol modulators. The organization has discovered more than 1,000 selective proprietary cortisol modulators and has a history including the FDA approval of Korlym (mifepristone) for hypercortisolism. Today, Corcept advances cortisol modulation across multiple disease areas and ongoing studies in endocrinology, oncology, metabolism, and neurology. The Associate Director, Clinical Records will provide strategic leadership and oversight for Corcepts Trial Master File (TMF) management processes across all clinical programs. This role is responsible for governance, quality, compliance, and inspection readiness of clinical documentation from study start-up through final archival. As a subject matter expert in eTMF operations and Veeva Vault, the Associate Director will drive innovation, ensure consistency across programs, and partner cross-functionally to support inspection readiness and regulatory compliance. This role requires a proactive and collaborative leader with a strong command of global TMF best practices, system optimization, and strategic planning within a GCP-regulated environment. Pay and Benefits
are as described in the job posting: see base pay range below and company information within this notice. Responsibilities
Provide strategic oversight and governance by leading the development and continuous improvement of TMF strategies, standards and procedures across all clinical programs Define and execute the long-term vision for clinical records and eTMF infrastructure, including risk mitigation, scalability and compliance Provide leadership and cross-functional collaboration by serving as the enterprise-wide TMF subject matter expert, offering guidance to clinical study teams, Quality Assurance and Regulatory Affairs Act as the primary TMF liaison during audits and inspections, ensuring readiness and addressing findings through corrective actions and continuous process improvement Collaborate with study teams to proactively manage TMF quality, regulatory compliance and inspection preparedness Establish and monitor KPIs and metrics to ensure ongoing TMF completeness, accuracy and timeliness; escalate risks and drive resolution Implement quality control measures, periodic reviews and oversight mechanisms to ensure compliance with global and local regulatory requirements Provide Veeva Vault oversight and system optimization by leading the configuration and lifecycle management of Corcepts Veeva Vault eTMF system Oversee vendor and license management, user training, validation activities and system upgrades in partnership with IT and QA Develop and maintain TMF-related SOPs, policies and work instructions aligned with ICH-GCP, the DIA Reference Model and evolving regulatory expectations Design and deliver training programs to internal staff and external partners to ensure alignment with Corcepts TMF processes and standards Identify and implement process enhancements and technology solutions to streamline document workflows and support clinical development goals Stay current with industry trends and regulatory developments to evolve Corcepts TMF strategies and ensure continuous inspection readiness Preferred Skills, Qualifications and Technical Proficiencies Deep expertise in Veeva Vault eTMF, including configuration, reporting and system administration Strong knowledge of DIA Reference Model, ICH-GCP and global regulatory requirements for clinical documentation Demonstrated success in leading cross-functional initiatives, driving compliance and supporting regulatory inspections Excellent skills in project management, stakeholder engagement and process improvement Strategic thinker with strong analytical skills and a collaborative leadership style Preferred Education and Experience 8+ years of experience in clinical records management with at least 3 years in a leadership or strategic role "The pay range that the Company reasonably expects to pay for this headquarters-based position is $185,000 - $205,600; 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. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept. Seniority level
Director Employment type
Full-time Job function
Health Care Provider
#J-18808-Ljbffr