Geared toward candidates comfortable with GxP system management and cross-functional collaboration, this role favors individuals with a background in clinical systems and regulatory environments, and who are prepared for a hybrid work arrangement in Redwood City.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Corcept Therapeutics
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 optimize future system deployments
Drive system reliability and operational excellence by partnering with IT and vendors to turn performance and support insights into proactive issue resolution and functional improvements
Preferred Skills, Qualifications and Technical Proficiencies:
Deep understanding of GCP and GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP5)
Results-driven leader with exceptional attention to detail and track record of delivering high-quality business outcomes in complex, fast-paced, and highly regulated environments
Proven ability to prioritize competing demands, solve complex business challenges, and translate strategic goals into innovative solutions and measurable outcomes
Preferred Education and Experience:
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 (pharmaceutical, biotech, medical device)
Experience supporting clinical systems, including CTMS, eTMF, and R&D information platforms
The pay range that the Company reasonably expects to pay for this headquarters-based position is $193,770-$227,880; 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.
Source: Corcept Therapeutics careers