Senior Development Systems Lead - GxP, CTMS & eTMF

Corcept Therapeutics

Redwood City (CA)

Hybrid

USD 194,000 - 228,000

Full time

8 days ago

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Job summary

Corcept Therapeutics is seeking a Senior Manager, Development Systems to design and scale development operations ecosystems, integrating Medidata Rave CTMS, Veeva eTMF, and related IIS applications. You will align GxP processes, lead system releases, and ensure data integrity and regulatory compliance across Clinical Development and IT teams.

You will partner with QA, Clinical Operations, Data Management, and vendors, driving change management, training, and cross-functional adoption of new

Qualifications

  • Bachelor’s degree in Computer Science, Data Science, Life Sciences, or a related field.
  • 5 years of experience in GxP application support and project management.
  • Experience with CSV and system change controls in a GxP regulated environment.

Responsibilities

  • Lead configuration, administration, and lifecycle management of GxP applications to ensure compliance and reliability.
  • Coordinate with QA to map processes, develop SOPs, and train staff for compliance and operational excellence.
  • Oversee data migration, validation plans, and vendor releases to maintain data integrity and regulatory readiness.

Skills

CSV & change control
GxP compliance
Project management
Rave CTMS
Veeva eTMF

Education

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

Tools

Rave CTMS
Veeva eTMF

Job description

Corcept Therapeutics is seeking a Senior Manager, Development Systems to design and scale development operations ecosystems, integrating Medidata Rave CTMS, Veeva eTMF, and related IIS applications. You will align GxP processes, lead system releases, and ensure data integrity and regulatory compliance across Clinical Development and IT teams.

You will partner with QA, Clinical Operations, Data Management, and vendors, driving change management, training, and cross-functional adoption of new

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