Regional Director
Houston, TX
Full Time
Clinical Operations
Senior Manager/Supervisor
Regional Director
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
KNOWLEDGE & EXPERIENCE
Education:
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
- 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
- ACRP- PM, ACRP-CP or equivalent preferred
- 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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