Executive Director of Operational Compliance, Care Access
More information about location
Decentralized clinical research & trial services
Job no longer available
Decentralized clinical research & trial services
501-1000 employees
Job no longer available
More information about location
501-1000 employees
Company mission
To engage every healthcare professional in clinical research and to make clinical trials a care option for every patient.
Role
Who you are
- 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
- Strong preference for candidate with experience in healthcare and/or clinical trials industry
- Typically requires 8 – 10 years of relevant experience
What the job involves
- 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
- Leadership & Strategic Direction:
- 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
- Source Creation & Management:
- 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
- SOPs and Policy Development:
- 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
- Clinical Training:
- 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
- Regulatory Compliance & Risk Management:
- 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
- Cross-Functional Collaboration & Communication:
- 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
- Continuous Improvement:
- 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
Our take
Through a network of distributed clinical research sites, on-demand popup sites, mobile infrastructure, and traveling clinical professionals, Care Access allows for decentralized clinical trials - especially in underserved communities.
Decentralized and virtually managed trials exploded in popularity during the height of the pandemic, and now they look set to stay. Care Access, that was established before this boom, is hence in a strong position to lead the way as this type of trial becomes more mainstream.
The company acquired IBPClin, a clinical trial center in Brazil, in 2022. This highlights its intention to grow in South America as well as at home in the US. On top of this, it has opened a new clinical research site in Poland, in another move towards establishing a global presence.
Steph
Company Specialist at Welcome to the Jungle
Insights
Company
Company benefits
- PTO/Vacation days, sick days, Holidays
- 100% paid Medical, Dental, and Vision Insurance. 75% for dependents
- HSA plan Short-term disability, long-term disability, Life Insurance
- Continued Education Allowance
- Culture of growth and equality
- 401K plan and matching contribution
Company HQ
Downtown Crossing, Boston, MA
Leadership
Ahmad Namvargolian
(Founder & CEO)Was a Research Scientist at the Lawrence Berkeley National Laboratory in California. Holds a Master's in Public Policy from the University of Chicago.
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