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A Regional Director will provide leadership, project management, and oversight for multiple locations, to plan and conduct clinical trials concurrently in accordance with the Sponsor goals; Standard Operating Procedures (SOPs); Good Clinical Practices (GCP), and regulatory guidelines. A Regional Director is expected to plan, execute and meet organizational productivity goals.
Duties & Responsibilities
Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols
Managing and supervising the investigators, site management, clinical and administrative staff, assuring that each clinical trial meets enrollment targets and is conducted in accordance with the clinical protocol(s) as approved by the Sponsor, all regulatory organizations, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and regulatory guidelines
Identify potential areas of risk, set priorities for internal reviews, site monitoring (of investigative sites ), and review, and approve corrective actions needed
Create risk mitigation strategies
Coordinating and collaborating with the various cross functional departments e.g. Clinical Operations, Recruitment, Human Resources, Central Services, to identify strategies for improved subject outcomes, site operating efficiencies, optimum subject experience, and risk assessment action plans
Identifying areas for improvement and developing detailed process flows, policies, and procedures to ensure consistent quality data is collected across DM Clinical Research sites.
Directing and managing clinical operations personnel, including hiring, performance reviews, and termination
Monitoring and reporting protocol performance, timelines, and financial metrics on an ongoing basis to the management team, including the current status of the protocol
Any other matters as assigned by management
Knowledge & Experience
Education:
Bachelor’s Degree; in a field of Medicine, Science, Behavioral Science, Nursing, or 10+ years in a related field required
Masters degree preferred
Experience:
5-7 years experience in a managing high growth clinical research sites required
3+ years in multi study management required
3+ years in multi therapeutic clinical trial experience required
3+ years in team management required
Credentials:
ACRP- PM, ACRP-CP or equivalent preferred
Knowledge and Skills:
Excellent communication, organizational and problem-solving skills
Strong skills with MS Office and/or Google Suite
Expertise in Trial management and ICH-GCP guidelines and FDA Clinical Trial Guidelines
Strong attention to detail
Strong skills in multi-tasking and delegating tasks
Strong People Management skills
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Bfwoy4HSN7
Seniority level
Director
Employment type
Full-time
Job function
Business Development and Sales
Industries
Internet Publishing
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