Regional Director of Clinical Operations

The Regional Director of Clinical Operations plays a key leadership role in overseeing the daily operations of clinical research sites within a designated region. This position is responsible for ensuring adherence to clinical research regulations, fostering a collaborative and respectful environment, and driving operational excellence. The role focuses on staff leadership, patient recruitment, trial management, and achieving organizational goals in clinical research.

RESPONSIBILITIES:

Operational Leadership

• Lead and oversee clinical trial activities across multiple sites to ensure efficient planning, execution, and completion.
• Ensure all operations comply with regulatory standards, Good Clinical Practices (GCP), and internal SOPs.
• Develop and execute strategies aligned with organizational objectives and financial targets.
• Manage regional budgets to meet financial goals and support revenue generation for the Clinical Research Division.
• Coordinate with cross-functional teams to ensure smooth study execution and maintain high-quality standards.
• Negotiate agreements with external service providers when needed to enhance operations.

Team Leadership and Development

• Mentor and guide clinical operations staff, fostering a collaborative and growth-oriented environment.
• Conduct performance evaluations, provide feedback, and identify professional development opportunities.
• Ensure team members maintain required certifications and training for regulatory compliance.
• Organize regular project reviews and meetings to evaluate team and project performance.
• Promote teamwork, respect, and continuous improvement across the team.

Stakeholder Management

• Build strong relationships with clients, investigators, and stakeholders to ensure satisfaction and address concerns proactively.
• Serve as the primary contact for regional clinical operations and represent the organization at industry events.
• Collaborate with clients and stakeholders to align goals and enhance operational outcomes.

Quality Assurance and Compliance

• Maintain stringent quality control measures to uphold high standards in trial execution.
• Address compliance issues promptly to avoid disruptions and ensure regulatory adherence.
• Monitor ongoing studies for deviations and implement corrective actions as necessary.

Strategic Planning and Innovation

• Contribute to the formulation of strategic plans for regional and corporate growth.
• Identify opportunities for process improvements and operational efficiencies.
• Stay informed about industry advancements to integrate innovative practices into clinical operations.

QUALIFICATIONS:

Education

• Bachelor’s degree in a relevant field is required.
• Advanced degrees, RN or Nurse Practitioner licenses, PA-C, or SoCRA CCRP certifications are preferred but not mandatory.

Experience

• A minimum of 10 years of experience in clinical operations, with at least 5 years in a leadership role.
• Extensive knowledge of clinical trials and industry standards.
• Proven success managing multiple employees and locations is highly desirable.

Skills

• Strong leadership, organizational, and interpersonal abilities.
• Proficiency with Microsoft Office and familiarity with Clinical Trial Management Systems (CTMS).
• Analytical problem-solver with a detail-oriented approach.
• Capable of adapting to dynamic priorities and deadlines.
• Effective at coaching and developing team members to achieve high performance.
• Maintains confidentiality and builds trust across teams.

Additional Requirements

• Flexibility to travel frequently within the region.
• Availability of working non-standard hours when necessary.
• Capability to perform office-based tasks, including extended periods of sitting or standing and occasional lifting (up to 15 pounds).