Director of Clinical Operations

About Company: A leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, conducting in-patient and out-patient phase I-IV clinical research studies. 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, acute and chronic pain, diabetes and other illnesses, as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5,000+ completed trials, the company continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

About the Role: We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision.

Responsibilities:

• Lead and mentor the clinical operations team to promote a collaborative and efficient environment.
• Ensure protocol compliance and maintain high-quality standards across studies.
• Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies.
• Oversee human resources functions, including staff evaluations, recruitment, and training.
• Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies.
• Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators.
• Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation.
• Conduct study closeout procedures.
• Perform additional duties as needed to adapt to the evolving needs of the organization.
• Ensure compliance with all applicable regulations and guidelines, including FDA, ICH, and GCP.

Minimum Qualifications:

• Bachelor's degree in a scientific or healthcare-related field
• 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role
• Strong understanding of FDA, ICH, and GCP regulations and guidelines
• Strong communication, organizational, and leadership skills
• Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical 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

Preferred Qualifications:

• Phase I or early phase experience
• Bilingual in English and Spanish