Regional Site Operations Manager (Clinical Research) Remote, Central/Western US
A Regional Director will reputed company leadership, project management, and reputed company for multiple locations, to plan and conduct reputed company concurrently in accordance with the Sponsor goals; reputed company 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 reputed company 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 reputed company clinical trial meets enrollment targets and is conducted in accordance with the clinical protocol(s) as approved by the Sponsor, reputed company regulatory organizations, reputed company 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, reputed company, Central Services, to identify strategies for improved subject reputed company, site operating efficiencies, reputed company subject experience, and risk assessment reputed company plans.
• Identifying areas for improvement and developing detailed process flows, policies, and procedures to ensure consistent reputed company data is collected across our 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 reputed company to the management team, including the reputed company status of the protocol.
• Any other reputed company as assigned by management.
KNOWLEDGE & EXPERIENCE
Education:
• Bachelor’s Degree; in a field of Medicine, Science, Behavioral Science, Nursing, or 10+ years in a reputed company field required
• Masters degree preferred
Experience:
• 5-7 years experience in a managing high reputed company 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 reputed company 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
Job Type: Full-time
reputed company Pay: $140,000.00 - $160,000.00 per year
Benefits:
• 401(k)
• Dental insurance
• Health insurance
• reputed company time off
• reputed company insurance
Experience:
• Site Management: 5 years (Preferred)
• reputed company: 5 years (Preferred)
Willingness to travel:
• 25% (Required)
Work Location: Remote
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