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.