Senior Clinical Trial Manager at Corcept Therapeutics in Menlo Park, CA

Job Description:

• The Senior Clinical Trial Manager (CTM) will manage all clinical aspects of phase 1b-III clinical studies.

Responsibilities:

• Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
• Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
• Develop study budget and timelines with clear assumptions
• Track overall spend for the study over the course of the study
• Collaborate with Regulatory to prepare regulatory documents for submission to the FDA
• Maintain Trial Master File with assistance from Clinical Trial Associate
• Manage Investigational Product (IP)
• Manage safety reporting to sites and regulatory bodies
• Procure and manage contracts with CROs, study vendors and investigative sites
• Provide oversight of CROs, independent field monitors and other clinical vendors
• Review monitoring trip reports and track resolution of all action items and protocol deviations
• Co-monitor at investigative sites to evaluate study site and field monitor performance
• Collaborate with medical experts, clinical study sites, and clinical study vendors
• Some travel may be required
• Manage activities assigned to direct reports
• Provide frequent study updates to senior management upon request

Requirements:

• Minimum BS / BA (science or healthcare field) or nursing degree
• Minimum of 6 years of experience in a biotech or pharmaceutical company, leading cross-functional clinical activities

Preferred Skills, Qualifications, or Technical Proficiencies:

• Attention to detail and ability to prioritize tasks to meet critical deadlines
• Excellent verbal and written communication skills
• Able to collaborate effectively with the study team, cross-functional team members, and external partners
• Knowledge of ICH/GCP and FDA regulations
• Strong proficiency in Microsoft Office