Regional Director of Operations
22 hours ago
Regional Director of Operations – Clinical Research (East Coast)
We have recently partnered with a fast-growing, dynamic Site Network Organization in the US that is redefining the clinical trial landscape. This organization operates across multiple states and consistently delivers high-enrollment, high-impact studies in a fast-paced environment. They are currently seeking an experienced Regional Director of Operations to provide strategic leadership and operational oversight across their East Coast sites.
This is a unique opportunity to lead multiple locations, working on Phase I-IV studies in therapeutic areas including Vaccines, Obesity, Diabetes, Migraines, and General Medicine. The role offers the chance to influence clinical operations, optimize site performance, and ensure the delivery of high-quality data while maintaining regulatory compliance.
Key Responsibilities:
- Provide leadership, project management, and oversight for multiple clinical sites, ensuring trials are executed efficiently and in alignment with Sponsor goals, SOPs, GCP, and regulatory guidelines.
- Manage and supervise investigators, clinical and administrative staff, ensuring enrollment targets are met and studies are conducted in compliance with protocol and regulatory standards.
- Identify potential areas of risk, implement mitigation strategies, and ensure corrective actions are executed as needed.
- Collaborate with cross-functional teams (Clinical Operations, Recruitment, HR, Central Services) to optimize subject experience, operational efficiency, and data quality.
- Develop and refine site processes, policies, and procedures to ensure consistent high-quality outcomes across all sites.
- Directly manage clinical operations personnel, including hiring, performance management, and development.
- Monitor and report on protocol performance, timelines, and financial metrics to leadership.
Qualifications & Experience:
- Bachelor's degree in Medicine, Science, Behavioral Science, Nursing, or 10+ years of equivalent clinical research experience required; Master's degree preferred.
- 5-7 years of experience managing high-growth clinical research sites.
- 3+ years of experience managing multiple studies and therapeutic areas.
- Proven team management experience and strong leadership skills.
- ACRP-PM, ACRP-CP, or equivalent certification preferred.
- Deep knowledge of FDA regulations, ICH-GCP guidelines, trial management, and site operations.
- Excellent communication, organizational, and problem-solving skills; strong proficiency in MS Office and/or Google Suite.
Why This Role is Exciting:
This is an opportunity to be part of a rapidly expanding organization at the forefront of clinical research. You will work in a high-energy, high-enrollment environment, directly influencing the success of multiple studies and therapeutic areas while driving operational excellence across the East Coast.
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