{bc}
Apply
greenhouse

Senior Manager, Development Systems

Corcept Therapeutics
Redwood City, USA
Senior · 5+ years experience
Onsite
Discovered 3 days ago

Full Job Posting

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.

Qualifications

  • Bachelor’s degree in Computer Science, Data Science, Life Sciences, or a related field

Apply for this job in 1 click

Skip the repetitive application forms

Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.

Sarah M.James T.Maya R.

Trusted by over 500,000 job seekers on Base Career

Start Free Today

More from this employer

More jobs at Corcept Therapeutics

Senior Medical Director, Oncology

Redwood City, USA

Discovered 3 days ago

Senior Clinical Trial Manager (Sr CTM)

Redwood City, USA

Discovered 3 days ago

Manager, Internal Events and Community

Redwood City, USA

Discovered 3 days ago

Senior Medical Director, Therapeutic Area Safety Physician - Endocrinology and Metabolic

Redwood City, USA

Discovered 3 days ago

Clinical Trial Manager (CTM)

Redwood City, USA

Discovered 3 days ago

Associate Director, Regulatory Affairs

Redwood City, USA

Discovered 3 days ago

Senior Manager/Associate Director, Product Complaints and Investigations

Redwood City, USA

Discovered 3 days ago

Senior Manager, Pipeline & Portfolio Market Planning

Redwood City, USA

Discovered 3 days ago