Clinical Trial Manager (CTM)

Corcept is seeking a Clinical Trial Manager (CTM) to independently manage clinical aspects of medium to large clinical studies. The role will work closely with cross-functional teams, vendors, sites, and CRO to ensure compliance with protocol and clinical objectives.

Requirements

• Implementation and quality execution of assigned clinical protocols
• Study management and vendor oversight
• Providing project-specific training and guidance to Clinical Research Associates
• Developing clinical trial protocol synopsis, protocols, and amendments
• Evaluating study designs and suggesting feasible solutions
• Tracking and managing study execution to resources and goals
• Facilitating CRO/Vendor selection process
• Escalating concerns regarding timelines and milestones
• Creating a process for developing and tracking essential trial documents
• Collaborating with team CRAs to ensure essential trial documents are provided to Regulatory
• Developing and ensuring compliance with clinical monitoring plan
• Managing oversight of Investigational Product (IP) accountability
• Managing safety reporting to sites and regulatory agencies
• Procuring and managing contracts with CROs, study vendors, and investigative sites
• Ensuring monitoring trip reports are reviewed and track resolution of action items
• Co-monitoring at investigative sites
• Managing study-wide activities such as external vendors, sample handling, and investigator payments
• Serving as in-house contact for protocol-related process questions
• Helping audits clinical data reports for accuracy, safety, and/or efficacy trends
• Exercising sound judgment to resolve protocol and drug questions, safety, regulatory, and legal questions

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance