Senior Manager, Development Systems

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . Corcept is hiring a Senior Manager, Development Systems. This is a pivotal role in shaping the future of our development operations ecosystems landscape. You will lead and scale innovative solutions and data integrations across Medidata Rave CTMS, Veeva eTMF, Veeva Study Training, and Investigator-Initiated Studies (IIS) applications—strengthening compliance, accelerating clinical operations, and delivering meaningful business impact. This role reports to Director, Development Systems and is a key strategic partner across Clinical Development, Clinical Operations, Data Management, IT, Quality Assurance, and technology vendors, translating business needs into scalable technical solutions while ensuring compliance and data integrity. Serving as the Development Systems subject matter expert (SME), this role will establish organizational change management strategies, build adaptability, drive cross-functional adoption of technology and processes, and delivery operational excellence across Development functions. This is a hybrid role typically requiring on-site presence 3 days per week. Responsibilities: GxP System Management & Business Process Alignment • Partner with business stakeholders and QA to map end-to-end business processes and develop SOPs, work instructions, and training materials that drive compliance and operational consistency • Lead the configuration, business administration, and lifecycle management of GxP applications to ensure reliable performance, regulatory compliance, and alignment with evolving business needs • Analyze vendor release notes and perform technical and regulatory impact assessments to mitigate system risks and maintain GxP compliance during vendor releases • Manage GxP system release projects end-to-end from planning, risk assessment, change control, and validation through deployment—measuring success 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 lifecycle documentation, including specifications, migration plans and requirements, and validation deliverables, to ensure data integrity and GxP compliance • Conduct GxP system periodic and audit trail reviews to ensure inspection readiness Operational Excellence & Organization Change Management • Partner with BPO to design comprehensive change management strategies and end-user support materials. Manage system release communications and training to enable successful system adoption, ensure business process compliance, and enhance 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, leverage system knowledge to continuously optimize training, support, and release rollout strategies • Spearheads post-release reviews to capture lessons learned, elevate cross-functional transparency, and implement process enhancements that o