Executive Director, Operational Compliance

What We Do
Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.

Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.

Position Overview

The Executive Director, Operational Compliance will lead the development, implementation, strategic direction, and continuous improvement of compliance frameworks across all operational areas across the company. This position will be responsible for embedding and upholding quality standards and support the development and implementation of operationally realistic processes. Review quality related metrics to determine risks and trends to support implementation of operational efficiencies. This includes overseeing teams responsible for Source development, creating and maintaining company SOPs and policies, and Training. The role ensures that all operational processes are aligned with regulatory requirements, industry best practices, and organizational standards, while driving strategic initiatives to enhance compliance, efficiency, and quality across the organization.

What You’ll Be Working On
Duties include but not limited to:

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

Physical and Travel Requirements

· This role requires up to 50% travel requirements. Length of travel will depend upon business requirements, staff needs, and company initiatives. Change the percentage of travel as needed.

What You Bring

Knowledge, Skills, and Abilities:

· 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.

Certifications/Licenses, Education, and Experience:

· Prior leadership experience managing multiple teams/functions.
· Strong preference for candidate with experience in healthcare and/or clinical trials industry.
· Typically requires 8 – 10 years of relevant experience.

Diversity & Inclusion

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the
physicians and caring for patients.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

Employment Statement

Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.