Clinical Operations Manager

Reports to: Medical Director (MD)

Position Summary

This individual will collaborate with researchers, physicians, and external partners to ensure the successful execution and growth of the hospital’s clinical research portfolio.

Key Responsibilities

Clinical Trial Identification & Strategy:

• Research and evaluate potential clinical trials and partnerships to expand the hospital’s portfolio of research opportunities.
• Analyze emerging medical trends, therapies, and clinical research areas to identify new trial opportunities aligned with institutional priorities.
• Build and maintain relationships with sponsors, Contract Research Organizations (CROs), and academic/research partners.

Clinical Operations Oversight:

• Manage the operational aspects of ongoing and upcoming clinical trials, ensuring compliance with protocols, timelines, and budgets.
• Collaborate with Principal Investigators (PIs) to develop operational plans for new trials, including staffing, facilities, and logistical needs.
• Monitor trial progress and troubleshoot operational challenges to ensure high-quality execution.

Regulatory Compliance & Quality Assurance:

• Ensure all clinical research activities comply with federal regulations (FDA, GCP, IRB) and hospital policies.
• Oversee the preparation and submission of regulatory documents, including trial initiation packages and Institutional Review Board (IRB) applications.

Team Leadership & Collaboration:

• Supervise clinical research staff, providing training, mentorship, and performance feedback.
• Foster a collaborative environment between the research team, physicians, and hospital departments.
• Act as a liaison between the hospital and external trial sponsors or CROs.

Financial Oversight:

• Assist in the preparation of budgets for clinical trials and ensure adherence to financial guidelines.
• Review contracts and budgets to ensure alignment with institutional goals and financial sustainability.

Qualifications

Education & Experience:

• Bachelor’s degree in a life sciences, healthcare, or related field required; Master’s degree preferred.
• Minimum of 5+ years of experience in clinical operations, clinical research, or a similar role, preferably within a private clinical trial organization or medical practice.
• Proven experience identifying and securing clinical trial opportunities.

Skills & Competencies:

• Strong understanding of clinical trial processes, including protocol development, patient recruitment, and regulatory compliance.
• Knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB processes.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work collaboratively with multidisciplinary teams and external stakeholders.
• Proficiency in clinical trial management systems (CTMS) and Microsoft Office Suite.

Certifications:

• Certified Clinical Research Professional (CCRP) or equivalent certification is a plus.

• Be a part of cutting-edge medical research and innovation.
• Collaborate with world-class physicians and researchers in a supportive, mission-driven environment.
• Competitive salary and benefits package, including healthcare, retirement plans, and professional development opportunities.