Elite Clinical Network · 15 hours ago
Associate Director of Quality
United States
Full-time
Remote
Lead/Staff, Director/Executive
5+ years expElite Clinical Network is seeking an Associate Director of Quality to lead and improve the quality assurance framework across its clinical research sites. This role involves ensuring compliance with regulatory requirements and overseeing quality assurance practices throughout the organization.
Consumer SoftwareHealth CareMarket ResearchPharmaceutical
Responsibilities
Work closely with Operational Leaders, Site Managers, and Clinical Research Coordinators to integrate quality practices into daily operations
Establish quality policies and a robust compliance infrastructure to standardize processes and mitigate risk across all network sites
Develop and deliver specialized GCP, regulatory compliance, and quality assurance training programs for site staff across the network, ensuring all personnel maintain the required level of competence. Ensure the maintenance of accurate and auditable training records for all clinical personnel across the network
Manage the SOP lifecycle, including drafting, reviewing, approving, distributing, and ensuring consistent implementation of standardized operating procedures across all network sites
Design and execute a comprehensive, risk-based internal auditing program for all clinical sites to proactively identify areas of non-compliance and systemic issues
Develop and track metrics to monitor GCP compliance trends and the effectiveness of network-wide operational controls. Analyze network-wide compliance data and quality metrics to identify systemic weaknesses and drive continuous process improvement initiatives across all sites
Host and attend external audits and regulatory inspections (e.g., FDA/EMA inspections) by sponsors or health authorities and manage preparation and follow-up for the on-site inspection process
Serve as the primary quality and regulatory expert resource for all clinical research sites in the network, interpreting complex regulations
Participate in strategic planning for process improvement, focusing on standardization and high-quality data integrity throughout the trial lifecycle
Qualification
Required
Education: Bachelor's degree in life science, healthcare, or related field
Experience: Minimum of 5 years of experience in Quality Assurance or Quality Control within the clinical research or pharmaceutical industry
Technical Skills/Systems Experience: Extensive, expert-level knowledge of ICH-GCP guidelines, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812), and HIPAA
Other Requirements: Ability to travel to network sites as required (Estimated 40% travel)
Preferred
Minimum of 3 years of management or leadership experience in a multi-site or network environment
Experience managing quality during rapid organizational growth or system integration across multiple locations
Demonstrated experience presenting complex compliance issues and strategic solutions to executive management
Company
Elite Clinical Network
Elite Clinical Network operates pharmaceutical research sites and provides physician specialties as well as a candidate database.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$200MKey Investors
MGG Investment Group
2023-09-08Debt Financing· $200M
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