Director of Clinical Operations

at  Be Well Clinical Studies

Be Well Clinical Studies is a leading organization dedicated to advancing medical research through high-quality clinical trials. We specialize in a diverse range of therapeutic areas and are committed to improving patient outcomes by bringing innovative treatments to market. Our team is passionate about clinical research and upholds the highest standards of integrity and excellence.
Position Overview: We are seeking an experienced and dynamic Director of Clinical Operations to lead and oversee our clinical operations across multiple sites. The successful candidate will be responsible for ensuring the smooth and efficient execution of clinical trials, maintaining regulatory compliance, and fostering a collaborative environment across all clinical research sites. This role requires a strategic thinker with strong leadership skills and a deep understanding of clinical trial management.

• Leadership and Management:
• Provide strategic direction and leadership to the clinical operations team, ensuring alignment with organizational goals.
• Manage and mentor site managers and clinical research coordinators to ensure high performance and professional development.
• Oversee the recruitment, training, and retention of clinical operations staff.
• Operational Oversight:
• Ensure the efficient and effective conduct of clinical trials across all sites.
• Develop and implement standard operating procedures (SOPs) to ensure consistency and quality in clinical trial execution.
• Monitor and report on the progress of clinical trials, including timelines, budgets, and quality metrics.
• Regulatory Compliance:
• Ensure all clinical trials are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
• Oversee the preparation and submission of regulatory documents and responses to regulatory agencies.
• Maintain up-to-date knowledge of regulatory requirements and industry best practices.
• Quality Assurance:
• Develop and implement quality assurance programs to ensure data integrity and patient safety.
• Conduct regular site audits and inspections to ensure adherence to protocols and SOPs.
• Address and resolve any compliance issues or deviations from protocols.
• Industry Collaboration:
• Foster strong relationships with investigators, sponsors, CROs, and other partners.
• Serve as the primary point of contact for escalated issues and inquiries related to clinical operations.
• Participate in sponsor meetings, site initiation visits, and other key events.
• Financial Management:
• Develop and manage budgets for clinical operations, ensuring cost-effective use of resources.
• Oversee financial reporting and forecasting for clinical trials.
• Identify and implement cost-saving measures without compromising quality or compliance.
• Bachelors degree in a related field; advanced degree preferred (e.g., MPH, MBA, PharmD).
• Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role.
• Proven track record of managing multi-site clinical operations.
• Deep understanding of GCP, FDA regulations, and other relevant guidelines.
• Strong leadership, communication, and interpersonal skills.
• Excellent organizational and problem-solving abilities.
• Ability to travel as needed to various clinical sites.