Senior Manager, Development Systems

Corcept Therapeutics Incorporated; Redwood City (CA); Hybride; USD 194 000 - 228 000; Plein temps

Résumé du poste

Corcept Therapeutics Incorporated is seeking a Senior Manager, Development Systems to lead and scale development operations ecosystems, integrating Medidata Rave CTMS, Veeva eTMF, and related tools to ensure compliance and data integrity.

You will partner across Clinical Development, Clinical Operations, Data Management, IT, QA, and vendors, translating business needs into scalable technical solutions while driving organizational change management and adoption.

Qualifications

• Bachelor’s degree in CS/Data Science/Life Sciences or related field.
• 5 years of GxP application support experience.
• 5 years of CSV and system change controls in GxP regulated environment.

Responsabilités

• GxP system management and alignment with business processes.
• Develop SOPs, work instructions, and training materials for compliance.
• Lead configuration and lifecycle management of GxP applications.

Connaissances

GxP regulations

Leadership

Regulatory compliance

Data integrity

Formation

Bachelor’s degree in Computer Science

Bachelor’s degree in Data Science

Bachelor’s degree in Life Sciences

Outils

CTMS (Medidata Rave)

Veeva eTMF

Veeva Study Training

Description du poste

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.