Senior Clinical Trial Operations Lead

Regulatory Jobs; Redwood City (CA); Hybrid; USD 171,000 - 201,000; Full time

Job summary

Corcept Therapeutics, headquartered in Redwood City, CA, seeks a Senior Clinical Trial Manager to shape and scale its clinical operations and SOP framework. The role may independently manage operational study aspects and involves cross-functional collaboration with sites, CROs, and internal teams in a hybrid setup with on-site presence three days per week.

The ideal candidate has 8+ years in biotech/pharma, a BS/BA or nursing degree, and deep knowledge of US GCP/ICH regulations, plus strong MS

Qualifications

• Knowledge of US GCP/ICH regulations and clinical trials processes.
• Ability to read and interpret scientific literature and medical terminology.
• Strong proficiency with Microsoft Office and related clinical documentation tools.

Responsibilities

• Lead cross-functional clinical activities and outsourcing to CROs.
• Develop and maintain SOPs and inspection-ready documentation.
• Manage study timelines, budgets, and regulatory submissions.
• Coordinate with Clinical Development and Medical Writing on protocols and amendments.
• Ensure the Trial Master File is complete and audit-ready.
• Oversee vendor selection and contract negotiations.

Skills

US GCP/ICH regulations

Clinical trials process

Medical terminology

Reading scientific literature

Education

BS/BA or Nursing degree

Tools

Microsoft Office

Job description

Corcept Therapeutics, headquartered in Redwood City, CA, seeks a Senior Clinical Trial Manager to shape and scale its clinical operations and SOP framework. The role may independently manage operational study aspects and involves cross-functional collaboration with sites, CROs, and internal teams in a hybrid setup with on-site presence three days per week.

The ideal candidate has 8+ years in biotech/pharma, a BS/BA or nursing degree, and deep knowledge of US GCP/ICH regulations, plus strong MS