Manager, Regional Clinical Operations

Manager, Regional Clinical Operations

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

The Manager, Regional Clinical Operations, coordinates and oversees site management activities for clinical studies conducted by Corcept Therapeutics. This role provides leadership to Regional CRAs and ensures compliance with ICH-GCP guidelines, contributing to the successful execution of monitoring activities. The position requires proactive communication, strategic planning, risk management, and strong organizational skills to support Corcept's Clinical Operations objectives.

Responsibilities :

• Lead and manage Regional CRAs assigned to the project, ensuring adherence to productivity and quality metrics outlined in the Clinical Monitoring Plan
• Oversee site management activities, including protocol deviation and safety reporting, action item resolution, GCP compliance and site allocation
• Monitor study progress, identify risks and trends, and escalate issues promptly to the Study Management Team (SMT)
• Participate in SMT meetings, providing updates on site metrics and study status
• Contribute to the development and review of study-specific documents, including Clinical Monitoring Plans, site logs, and monitoring tools (e.g., SQV / SIV slides, MV agendas, checklists)
• Review and approve monitoring trip reports and follow-up letters
• Conduct periodic co-monitoring visits to assess site performance and CRA effectiveness
• Support resource planning, site assignments, and performance throughout the study lifecycle
• Ensure proper maintenance and quality of site eTMF, including periodic audits
• Mentor and evaluate Regional CRAs, contributing to performance assessments and professional development
• Promote solution-oriented thinking and effective issue resolution across studies

Preferred Skills, Qualifications and Technical Proficiencies :

Preferred Education and Experience :

The pay range that the Company reasonably expects to pay for this position is $151,800 - $198,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

#LI-Remote

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

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.