Associate Regional Director (4121)

The Associate Regional Director, Clinical Operations, supports operational leadership across multiple DM Clinical
Research sites within an assigned geographic region. This role is responsible for ensuring successful clinical trial
execution, enrollment performance, regulatory compliance, and operational consistency.

The Associate Regional Director partners with Site Directors, investigators, and executive leadership to optimize
study performance, scale clinical capabilities, and support the organization’s growth objectives.This role supports
regional performance, including enrollment, financial outcomes, quality metrics, and operational efficiency.

This role reports directly to the Vice President of PMO and Clinical Strategy, with a dotted-line relationship to the
Chief Operating Officer to ensure alignment with operational priorities, site performance, and organizational
objectives.

DUTIES & RESPONSIBILITIES

1. Regional Operations Leadership

• Provide operational leadership across multiple clinical research sites within the assigned region
• Oversee regional performance, including enrollment targets, site productivity, and operational efficiency
• Drive consistency in processes, systems, and execution across sites
• Support regional growth initiatives, including new site activation, investigator onboarding, and expansion of clinical trial capabilities
• Partner with executive leadership to align regional operations with organizational strategy

2. Clinical Trial Execution

• Ensure successful execution of clinical trials across all sites in alignment with protocol requirements and sponsor expectations
• Oversee study timelines, enrollment progress, and site utilization
• Identify and address enrollment barriers; implement strategies to improve recruitment and retention
• Conduct operational site reviews to assess protocol execution, enrollment performance, and readiness

3. Quality & Compliance Oversight

• Ensure adherence to GCP, FDA regulations, SOPs, and sponsor requirements across all sites
• Monitor and support improvement of quality metrics, including protocol deviations, audit outcomes, and inspection readiness
• Proactively identify operational, enrollment, and regulatory risks and implement mitigation strategies to ensure study timelines, enrollment targets, and quality standards are consistently achieved
• Promote a culture of quality, compliance, and continuous improvement

4. Staff Leadership & Development

• Provide leadership and performance oversight for Site Directors, Clinical Research Coordinators (CRCs), and site support staff
• Coach and develop site leadership to improve performance, accountability, and execution
• Support hiring, onboarding, and retention strategies across the region
• Foster a high-performance, collaborative culture across sites

5. Performance Reporting & Financial Management

• Accountable for regional KPIs, including:
  • Study enrollment targets
  • Protocol timelines and study start-up metrics
  •  Site utilization and productivity
  • Revenue contribution and financial performance
  • Quality indicators (deviations, audits, compliance metrics)
• Analyze performance data and implement action plans to improve outcomes
• Partner with finance and leadership to manage budgets, forecasting, and resource allocation

KNOWLEDGE & EXPERIENCE

Education:

• Bachelor's degree required; advanced degree preferred.

Experience:

• 8+ years of clinical research experience
• 3–5 years of leadership experience managing multi-site or multi-functional teams
• Demonstrated experience driving enrollment performance, operational efficiency, and site-level financial outcomes
• Experience supporting or leading site growth initiatives, including new site activation and investigator engagement preferred

Credentials:

• Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred

Knowledge and Skills:

• Deep knowledge of clinical trial operations in a multi-site environment
• Strong understanding of GCP, FDA regulations, and compliance standards
• Proven ability to drive enrollment, timelines, and site performance
• Strong operational leadership and multi-site management capability
• Financial acumen, including site revenue and performance drivers
• Ability to use KPIs and data to drive decision-making and performance improvement
• People leadership and coaching skills across Site Directors and site teams
• Ability to proactively identify and mitigate operational, enrollment, and regulatory risks
• Strong cross-functional collaboration with investigators, sponsors, and leadership
• Strategic thinking with focus on site growth, investigator engagement, and operational scaling
• Strong communication and ability to influence and drive accountability

Key Accountabilities:

• Achievement of regional enrollment targets
• Regional site financial performance and revenue contribution
• Study execution, including timeline adherence and start-up performance
• Quality and regulatory compliance outcomes (deviations, audits, inspection readiness)
• Investigator engagement, relationships, and retention
• Multi-site operational scalability, efficiency, and performance optimization