Senior Clinical Trial Manager (Sr CTM)

Preferred Education and Experiencenice to have

• Relevant BS / BA degree or nursing degree
• 8+ years' experience in a biotech or pharmaceutical company, leading cross-functional clinical activities
• Management experience including outsourcing to Contract Research Organization (CRO)

• Proactively identify gaps in workflows and documentation, and designing scalable, inspection-ready SOPs and processes that enable high-quality study execution
• Author updates, and continuously improve SOPs, work instructions, templates, and forms to ensure they are lean, practical, and aligned with ICH-GCP E6 (R2/R3) standards
• Evaluate the downstream impact of SOP and process changes on ongoing trials, vendor contracts, and clinical systems (e.g., CTMS), ensuring seamless adoption without disrupting active programs
• Facilitate cross-functional SOP review and working groups
• Contribute to SOP governance, inspection readiness, and continuous improvement initiatives that strengthen Corcept’s clinical operations infrastructure
• Execute assigned clinical protocol with high quality according to Corcept SOPs, ICH/GCP, and corporate and departmental program goals
• Serve as a study lead to the multifunctional team to ensure clinical study/studies activities including study start-up, enrollment, maintenance, and close-out are executed per timeline and budget
• Work with Clinical Development and/or Medical Writing to generate clinical trial protocol synopsis, protocols, and protocol amendments
• Facilitate the CRO/Vendor selection process for outsourced activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions. This includes review of cope of ork, budgets, and negotiating contracts through execution
• Procure and manage contracts with CROs, study vendors, and investigative sites
• Develop critical study documents, including informed consent form templates, various management plans, and study trackers
• Develop study timelines and budgets per the corporate and departmental goals and continuously strive to ensure timelines are deliverables are met within budget
• Develop, distribute, review, and track essential trial documents and/or oversee CRO responsibility for essential documents
• Provide Regulatory with Site Essential Regulatory Documents for submission to the FDA and other regulatory agencies
• Manage or provide oversight of CROs, independent field monitors, and other clinical vendors
• Ensure monitoring trip reports are reviewed and track resolution of all action items and protocol deviations
• Manage, either directly or through supervised delegation, other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, data quality, and central records quality
• Audit clinical data reports for accuracy, safety, and/or efficacy trends and prepare related presentations
• Ensure the Trial Master File is maintained throughout the study in accordance with regulatory and company requirements