[Remote] Manager, Regional Clinical Operations at Corcept Therapeutics

Remote

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Willingness to travel 25% regionally and on occasion, cross-country
BS/BA in a science or healthcare field, or nursing degree
8+ years of experience that includes 5+ years CRA experience along with at least 2 years of leadership
Strong knowledge of ICH-GCP guidelines, eTMF requirements, and site start-up processes
Proven leadership and mentoring skills with a collaborative, problem-solving approach
Excellent interpersonal, oral, and written communication skills

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

Skills

Key technologies and capabilities for this role

ICH-GCPClinical MonitoringSite ManagementCRA ManagementRisk ManagementProtocol Deviation ManagementSafety ReportingStudy MetricsClinical Monitoring Plan

Questions & Answers

Common questions about this position

What education and experience are required for the Manager, Regional Clinical Operations role?

A BS/BA in a science or healthcare field or nursing degree is required, along with 8+ years of experience including 5+ years in a relevant role.

Is travel required for this position?

Yes, the role requires willingness to travel 25% regionally and occasionally cross-country.

What are the key skills needed for this role?

Proven leadership and mentoring skills with a collaborative, problem-solving approach, along with excellent interpersonal, oral, and written communication skills are required.

What is the salary or compensation for this position?

This information is not specified in the job description.

What leadership responsibilities does this role involve?

The role includes leading and managing Regional CRAs, mentoring and evaluating them, conducting co-monitoring visits, and promoting solution-oriented thinking.

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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