Headlands Research · 23 hours ago
Clinical Trials Quality Manager
United States
Full-time
Remote
Senior Level
5+ years expHeadlands Research is a leading network of advanced clinical trial sites dedicated to enhancing clinical trial delivery. The Clinical Trials Quality Manager will monitor the quality and consistency of data and clinical operations at network clinical research sites, ensuring adherence to best practices and regulatory compliance.
BiotechnologyHealth CareMedical
Responsibilities
Create and maintain new Standard Operating Procedures (SOPs), Work Instructions, and other guidance at the network and site levels in compliance with ICH-GCP and federal, state, and local regulations (United States and Canada) as applicable
Review and edit existing SOPs, work instructions, and other guidance at the network and site levels for compliance with applicable regulations (local to both the United States and Canada) and conformity to network SOPs
Support the development and delivery of network and site-level training events, as requested, in various formats
Conduct consistent internal study review activities to ensure compliance with ICH-GCP and applicable regulations (local to both the United States and Canada)
Prepare and deliver an official report detailing internal study review activities performed, categorize any findings based on level of risk, and propose actions to correct any issues or noncompliance
Work with the aligned operations team to remediate any issues or noncompliance identified at the site and implement preventive action as appropriate
Participate in other requested quality investigations
Assist site operations team to develop, implement, and track Corrective and Preventive Action plans (CAPAs) within the assigned region
Routinely assess and report to operations on the risks impacting each site in the assigned region
Conduct and report on the quality reviews of external sites as part of the Mergers & Acquisitions (M&A) due diligence process
Participate in the integration of newly acquired sites into the network according to the integration playbook
Share best practices to maintain a constant state of site inspection readiness
Attend external audits and provide updates to internal leadership
Track and assist in the required training of Headlands employees in the assigned region
Support the development and delivery of training materials for site employees (CRIO, applicable network systems, etc.)
Help site directors assess employee performance to quality standards, particularly in the 90-day probationary period after hire
Participate in continuing education opportunities to stay up to date on relevant quality initiatives, regulatory guidance, and industry best practices
Travel required up to 30%, domestically and/or internationally
Qualification
Required
Bachelor's degree or equivalent required
Will consider Associates Degree with 5+ years of equivalent experience
5+ years of experience creating, reviewing, and delivering SOPs, work instructions, and training to ensure consistent quality across sites
Experience conducting internal and external audits, monitoring inspections, and preparing formal quality reports
Demonstrated ability to develop, implement, and track corrective and preventive action plans (CAPAs)
Experience creating, reviewing, and delivering SOPs, work instructions, and training to ensure consistent quality across sites
Ability to identify quality risks, assess impact, and recommend corrective/preventive measures
Familiarity with decentralized or networked clinical trial operations, including multi-site management in US and Canada
Excellent knowledge of current federal and local regulations on clinical research and GCP
Demonstrates skills highly adaptable from another cGXP work environments
Extreme attention to detail
Ability to communicate and work effectively with a diverse team of professionals
Strong communication and organizational skills
Comfortable taking direction from supervisor or working with autonomy
Proficient computer skills and use of MS Office
Ability to build rapport with employees and external clients
Comfortable traveling up to 30% of the time, domestically or internationally (Canada)
Preferred
Certification by a professional clinical research organization preferred
Company
Headlands Research
Headlands Research is a globally integrated clinical trial site organization with a mission to improve the clinical trials process.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$29.19MKey Investors
Kohlberg Kravis Roberts
2025-08-14Acquired
2025-07-09Series Unknown· $1.35M
2024-11-01Series Unknown· $2M
Leadership Team
Kyle Burtnett
Chief Executive Officer
Recent News
2025-08-18
2025-08-17
Mergers & Acquisitions
2025-08-15
Company data provided by crunchbase