Executive Director, Operational Compliance

Summary

Join Care Access as the Executive Director, Operational Compliance and lead the development and implementation of compliance frameworks across all operational areas. You will oversee teams responsible for source development, SOP creation, and training, ensuring alignment with regulatory requirements and industry best practices. This role requires strategic direction, risk management, and cross-functional collaboration to enhance compliance, efficiency, and quality. You will provide strategic guidance to senior leadership and maintain a proactive approach to risk management. The position involves significant travel and requires extensive experience in leadership and compliance within healthcare or clinical trials.

Requirements

• Expert business knowledge with a comprehensive understanding of the organization and functional areas
• Comfortable developing and implementing company-wide policies and practices impacting multiple functions
• Experience assessing, identifying, and providing strategic direction to support with complex situations impacting multiple departments often working cross-functionally
• Establishes and develops short-term departmental strategy and translates into multi-functional objectives
• Comfortable interacting with and advising internal and external executive level management
• Prior leadership experience managing multiple teams/functions
• Typically requires 8 – 10 years of relevant experience

Responsibilities

• Lead the teams to ensure seamless integration of compliance standards across operations
• Develop and execute the compliance strategy, ensuring it aligns with business objectives and regulatory requirements
• Provide strategic direction to senior leadership on compliance-related matters, identifying emerging risks and opportunities for improvement
• Support audits and regulatory inspections
• Oversee the creation, implementation, and management of Source systems to ensure compliance with industry standards and regulations
• Work closely with internal teams to ensure eSource solutions are compliant, efficient, and scalable across sites and clinical operations
• Ensure that data integrity, security, and regulatory requirements are met within the Source platforms
• Lead the team to create, update, and enforce SOPs and policies to ensure regulatory compliance and efficiency as per local regulations
• Continuously revise SOPs and policies to stay aligned with current local / country regulations and best practices
• Collaborate with cross-functional teams to ensure alignment with corporate objectives and legal standards
• Oversee the development and execution of clinical training programs to ensure site teams are well-trained on compliance-related processes, regulations, and best practices
• Ensure that training programs are up-to-date, effective, and aligned with industry standards, improving compliance awareness and operational performance
• Evaluate training effectiveness and make adjustments to ensure continuous improvement and adherence to regulatory requirements
• Ensure full compliance with all applicable laws, regulations, and industry standards related to site management, clinical trials, and operational processes
• Maintain a proactive approach to risk management, addressing any compliance gaps or deviations promptly
• Partner with other senior leaders, including legal, clinical operations, and IT teams, to ensure compliance considerations are embedded in all organizational processes
• Foster a collaborative and transparent compliance culture by regularly communicating compliance objectives, updates, and results to stakeholders at all levels
• Serve as the primary point of contact for regulatory agencies, auditors, and external partners on compliance-related matters
• Lead continuous improvement initiatives to optimize compliance processes and operational efficiency across teams
• Leverage data and feedback to refine SOPs, policies, training programs, and eSource solutions
• Foster an environment of innovation and agility to adapt to changing regulatory landscapes and operational needs

Preferred Qualifications

Strong preference for candidate with experience in healthcare and/or clinical trials industry

Benefits

This role requires up to 50% travel requirements