Senior Clinical Trial Manager (Sr CTM)

Role Summary

The Senior Clinical Trial Manager (Sr. CTM) will shape and scale Corcept’s clinical operations processes and SOP framework. This role may independently manage operational aspects of clinical studies. The incumbent will work with cross-functional teams, vendors, clinical sites, and CROs to execute protocol requirements ensuring study deliverables, milestones, and objectives are met within timelines and budget. This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities

• 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 scope of work, 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

Qualifications

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

Skills

• Knowledge of US and GCP/ICH regulations
• Understanding of the clinical trials process, the application of SOPs, and medical terminology
• Ability to read and understand scientific literature
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools

Education

• Relevant BS/BA degree or nursing degree