About this opportunity
Barrington James Limited lists this Director of Clinical Operations opportunity in town of florida, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Our client is seeking a Director of Clinical Operations, Phase I, to oversee clinical trials, ensure protocol adherence, and manage staff and operational aspects of studies. Requires strict compliance with GCP, ICH guidelines and company SOPs, with core duties spanning staff management, protocol review, quality assurance and study supervision.
Responsibilities
Lead and mentor the clinical operations team, fostering a collaborative and efficient environment
Ensure protocol compliance and maintain high quality standards across studies
Partner with Principal Investigators and the Site Director to assign studies and develop enrollment strategies
Oversee HR functions including staff evaluations, recruitment and training
Monitor protocol adherence and report deviations to sponsors and regulatory bodies
Coordinate with the Site Director and Principal Investigators to assign clinical research coordinators
Review study components with PIs and Site Directors ahead of study initiation
Conduct study closeout procedures
Ensure compliance with FDA, ICH and GCP regulations
Minimum qualifications
Bachelor's degree in a scientific or healthcare related field
Phase I or early phase experience
7-10 years of clinical operations experience, including 5+ years in a senior leadership role
Strong understanding of FDA, ICH and GCP regulations and guidelines
Strong communication, organisational and leadership skills
Proficiency in Microsoft Word, Excel and clinical trial management software
In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management and study close-out
Experience managing and mentoring a team of clinical operations professionals
Bilingual in English and Spanish
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.