- 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
- Certification by a professional clinical research organization preferred
- Bachelor's degree or equivalent required
- Will consider Associates Degree with 5 years of equivalent experience
- 5+ years of experience in the clinical research industry required
- 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
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Quality Manager - Myrtle Point, United States - Headlands Research
Description
OverviewAt Headlands Research, we are building a best in class clinical trial network.
We're an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant engagement Founded in 2018, our company operates 18 clinical trial sites in the US and Canada with rapid plans for expansion.
The RoleThe Quality Manager is responsible for monitoring the quality and consistency of data and clinical operations at network sites in the United States and Canada.
This role will ensure that quality is built into all site processes and will partner with Headlands Operations employees to verify quality outcomes.
This role will help the company succeed by reinforcing adherence to best-in-class processes, Good Clinical Practice, and federal and local regulations related to clinical research.
Headlands employees are passionate about advancing healthcare.In this role, we hope you are just as passionate about supporting a patient experience that is safe, reliable, and compliant.
Excellent communication and deductive reasoning skills are essential. If you also have experience monitoring clinical research sites, we would like to connect with youResponsibilities
