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 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 advance 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.
Reporting to the Vice President of Development Operations, the Senior Manager of Clinical Records will manage the set-up, quality review, documentation, compliance improvement, and archival of study-specific Trial Master Files (TMFs) at Corcept in accordance with SOPs, industry best practice, and ICH/GCP guidelines.
Responsibilities:
- With input from the respective study teams, develops and maintains study TMF Plans and Indexes
- Serves as the Records Manager for all clinical trials at Corcept throughout the TMF lifecycle (i.e., from study start up to archiving)
- Working directly with the respective study teams, oversees execution of study TMF plans, ensuring all clinical study documentation is collected, handled, transferred, stored and/or entered into Corcept's Veeva Vault TMF in compliance with SOPs and global and local standards and requirements
- For all study TMFs, ensures quality, timeliness, and completeness by performing regular and ongoing reviews of study documents
- Identifies study specific TMF compliance gaps (missing or low-quality documents) and works collaboratively with study team and/or external vendors to resolve gaps quickly and completely
- Supports the respective study teams by proactively maintaining current Expected Document List (EDL) counts, and provides oversight reports, metrics, KPIs to the study teams and management
- Administrates and manages Corcept's Veeva Vault, including but not limited to setting-up studies in instance, managing licenses, and generating reports
- Assesses and configures Corcept's Veeva Vault to introduce improvements
- Works with Quality Assurance and Veeva to ensure instance remains in a fully validated state, and works with business teams to conduct and document risk impact assessments of software releases
- Applies consistent process and quality standards across all TMFs to always ensure audit-readiness
- Developments and maintains TMF and Veeva Vault-related work instructions and SOPs
- Develops and conducts training to educate internal staff and vendors about Corcept's Veeva Vault TMF business and system procedures and maintains training materials
- Participates in Quality Assurance audits and/or regulatory authority inspections
Preferred Skills, Qualifications and Technical Proficiencies:
- Deep experience with electronic document management systems, document archival systems, and clinical trial management systems
- Demonstrated mastery of the DIA Reference Model filing structure and contents
- Expert knowledge of cross-functional TMF content requirements
- Experience working with cross-functional reams to improve TMF quality, completeness, and timeliness
- Especially proficient in tracking, sorting, filtering, and managing large sets of metadata
- Excellent communication, interpersonal, and analytical skills
Preferred Education and Experience:
- 6 years of relevant experience, ideally including experience with Veeva Vault TMF
- 3 years of experience TMF QC Review
The pay range that the Company reasonably expects to pay for this headquarters-based position is $170,000 - $180,000; 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.
If you are based in California, we encourage you to read this important information for California residents linked here.
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
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