Senior Manager, Development Systems

Corcept Therapeutics•Redwood City, CA

1d•$193,770 - $227,880•Hybrid

About The Position

Corcept is hiring a Senior Manager, Development Systems to shape and scale its development operations ecosystem. The role leads solutions and data integrations across Medidata Rave CTMS, Veeva eTMF, Veeva Study Training, and Investigator-Initiated Studies (IIS) applications to strengthen compliance, accelerate clinical operations, and deliver business impact. Reporting to the Director, Development Systems, this strategic partner works with Clinical Development, Clinical Operations, Data Management, IT, Quality Assurance, and technology vendors. The position translates business needs into scalable technical solutions while maintaining compliance and data integrity. As the Development Systems subject matter expert, the role establishes organizational change management strategies, supports adaptability and cross-functional adoption, and drives operational excellence across Development functions. This is a hybrid role, typically requiring on-site presence three days per week.

Requirements

Deep understanding of GCP and GxP regulations, including FDA 21 CFR Part 11, EU Annex 11, and GAMP5.
Results-driven leadership, exceptional attention to detail, and a track record of delivering high-quality business outcomes in complex, fast-paced, highly regulated environments.
Ability to prioritize competing demands, solve complex business challenges, and translate strategic goals into innovative solutions and measurable outcomes.
Bachelor’s degree in Computer Science, Data Science, Life Sciences, or a related field.
5 years of firsthand experience in GxP application support and project management.
5 years of experience in CSV and system change controls in a GxP-regulated environment, such as pharmaceutical, biotech, or medical device.
Applicants must be currently authorized to work in the United States on a full-time basis.

Nice To Haves

Experience supporting clinical systems, including CTMS, eTMF, and R&D information platforms.

Responsibilities

Partner with business stakeholders and QA to map end-to-end business processes and develop SOPs, work instructions, and training materials that support compliance and operational consistency.
Lead configuration, business administration, and lifecycle management of GxP applications to ensure reliable performance, regulatory compliance, and alignment with business needs.
Analyze vendor release notes and conduct technical and regulatory impact assessments to mitigate system risks and maintain GxP compliance during vendor releases.
Manage GxP system release projects from planning, risk assessment, change control, and validation through deployment, measuring performance against approved timelines, validation acceptance criteria, release readiness, and post-release system performance.
Oversee clinical study data migration and integration initiatives by architecting secure data pipelines and developing specifications, migration plans and requirements, and validation deliverables to ensure data integrity and GxP compliance.
Conduct GxP system periodic reviews and audit trail reviews to maintain inspection readiness.
Partner with the BPO to design change management strategies and end-user support materials; manage release communications and training to support system adoption, business process compliance, and operational effectiveness.
Lead role-based system training and study onboarding for Rave CTMS and Veeva Clinical.
Establish processes to capture user feedback and monitor success metrics, and use system knowledge to optimize training, support, and release rollout strategies.
Lead post-release reviews to capture lessons learned, improve cross-functional transparency, and implement process enhancements for future system deployments.
Partner with IT and vendors to use system performance and support insights for proactive issue resolution and functional improvements.