Senior Clinical Trial Manager (Sr CTM)

Senior Clinical Trial Manager at Corcept Therapeutics will develop and scale clinical operations processes while independently managing operational aspects of clinical studies. The role involves cross-functional collaboration with sites, vendors, and CROs to ensure studies meet protocol requirements, timelines, and budgets.

Responsibilities

• Identify workflow gaps and design scalable, inspection-ready SOPs and processes for study execution
• Lead study operations as study lead, overseeing startup, enrollment, maintenance, and closeout activities
• Manage vendor and CRO selection, contracting, and performance throughout trials
• Develop and maintain critical study documents including protocols, informed consent forms, and management plans
• Establish study timelines and budgets while ensuring deliverables are met on schedule and within budget

Requirements

• Experience designing and implementing SOPs aligned with ICH-GCP E6 standards
• Demonstrated ability to manage clinical trial operations and vendor relationships
• Knowledge of clinical trial processes including startup, enrollment, and closeout
• Experience with contract negotiation and procurement for CROs and clinical sites
• Proficiency with clinical trial management systems and regulatory documentation
• Strong cross-functional collaboration and process improvement skills