Director of Clinical Operations

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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Worksite address

miami, FL, 33222, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.