Operations Manager, Clinical Trials

Who We Are

At Health Haven and Health Synergy Clinical Research , we are building a modern and integrated model of psychiatric care that combines high-quality outpatient treatment, interventional psychiatry, and industry-sponsored pharmaceutical clinical research.

Our mission is to provide compassionate, evidence-based mental health care while helping advance the future of psychiatric treatment through ethical clinical research and innovative therapeutic approaches. With continued expansion across Florida, our organization offers physicians the opportunity to grow within a collaborative, high-performing environment focused on clinical excellence, innovation, operational efficiency, and long-term professional development.

We are committed to creating an environment where physicians can thrive clinically, professionally, and financially while working alongside an experienced multidisciplinary team dedicated to exceptional patient care.

Who You Are

You are a highly organized and results-driven clinical research leader with a passion for operational excellence, participant care, and advancing innovative treatments through clinical research. You thrive in a fast-paced environment and possess the ability to balance study execution, team leadership, regulatory compliance, and business operations. You are a proactive problem-solver who builds strong relationships with sponsors, investigators, participants, and team members while maintaining a commitment to quality, compliance, and continuous improvement.

What You'll Do

You will oversee the day-to-day operations of the clinical research site, ensuring the successful execution of clinical trials while driving operational efficiency, participant recruitment, regulatory compliance, staff development, and sponsor satisfaction. You will serve as a key leader within the organization and help support the growth and success of the clinical research program.

• Clinical Trial Operations: Oversee all active clinical trials, ensuring protocol adherence, participant safety, study quality, and timely completion of study milestones
• Site Operations Management: Manage daily site operations, workflows, scheduling, staffing resources, equipment, and facility readiness to ensure efficient study execution
• Team Leadership & Development : Recruit, train, supervise, mentor, and evaluate Clinical Research Coordinators, Regulatory Specialists, Recruiters, Medical Assistants, and other site personnel
• Participant Recruitment & Retention: Develop and oversee recruitment and retention strategies to achieve enrollment goals and maintain an exceptional participant experience
• Sponsor & CRO Relations: Serve as the primary operational contact for sponsors and contract research organizations, coordinating site visits, feasibility assessments, and ongoing communications
• Study Startup & Activation : Support feasibility reviews, regulatory submissions, study startup activities, and site activation efforts to ensure efficient study launches
• • Regulatory Compliance : Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, IRB standards, and all applicable research regulations
• Quality Assurance: Maintain audit and inspection readiness through routine quality reviews, process improvement initiatives, and staff training
• Financial & Operational Performance : Monitor study performance metrics, operational efficiency, study profitability, and resource utilization while supporting organizational growth objectives
• Strategic Growth Support : Assist with business development efforts, sponsor relationship building, and identifying opportunities to expand the site's clinical trial portfolio
• Performance Monitoring : Track key operational metrics, enrollment performance, retention rates, and study timelines to drive continuous improvement
• Other Duties as Assigned

What You'll Bring

• Bachelor's degree required; Master's degree preferred
• 3+ years of clinical research experience required
• 3+ years of leadership, operations management, or supervisory experience preferred
• Experience managing industry-sponsored clinical trials required
• Strong knowledge of FDA regulations, ICH-GCP guidelines, HIPAA requirements, and human subject protections
• Experience leading multidisciplinary teams in a clinical or research environment
• Demonstrated ability to manage multiple studies, priorities, and deadlines simultaneously
• Strong understanding of participant recruitment, retention, and study startup processes
• Experience working with sponsors, CROs, monitors, and Principal Investigators
• Proficiency with CTMS, EDC systems, Microsoft Office Suite, and research-related software platforms
• Strong financial and operational acumen, including experience monitoring study performance and operational metrics
• Exceptional organizational skills and attention to detail
• Excellent interpersonal, communication, and relationship-building skills
• Strong critical thinking, problem-solving, and decision-making abilities
• Ability to work independently while fostering collaboration across teams
• Professionalism, adaptability, and a commitment to operational excellence
• Clinical research certifications (CCRC, CCRP, ACRP, or SOCRA) preferred
• Spanish language proficiency preferred

What We Offer

• Comprehensive Medical Plans
• Dental Insurance
• Vision Insurance
• Employer-paid Life Insurance
• Employee Assistance Program (EAP)
• Paid Vacation Time
• Paid Sick Time
• Paid Federal Holidays
• Referral Program
• Opportunities for growth and development

Equal Opportunity Employer We are an equal opportunity employer and comply with all applicable federal, state of Florida, and local employment laws. Employment decisions are made without regard to race, color, religion, sex, pregnancy, national origin, age, disability, genetic information, marital status, veteran status, or any other status protected by law. We are committed to maintaining a workplace free from discrimination, harassment, and retaliation, and to fostering an inclusive environment where all employees are treated with fairness, dignity, and respect.

All positions requiring Florida Care Provider Background Screening through the Clearinghouse are subject to background screening requirements under House Bill 531 (2025). For more information, please visit the Care Provider Background Screening Clearinghouse Education and Awareness website at https://info.flclearinghouse.com