Senior Clinical Trial Manager (Sr CTM)

Corcept Therapeutics•Redwood City, CA

1d•Hybrid

About The Position

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com. The Senior Clinical Trial Manager (Sr. CTM) will play a key role in shaping and scaling Corcept’s clinical operations processes and SOP framework. This position may also independently manage operational aspects of clinical study. This leader will work with cross-functional teams as well as vendors, clinical sites, and CROs to execute protocol requirements to ensure 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.

Requirements

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)
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
Applicants must be currently authorized to work in the United States on a full-time basis.

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 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