Integration Manager
Redox
Senior Quality Manager
Headlands Research
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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
Requirements
- 5+ years of experience in the clinical research industry required
- Certification by a professional clinical research organization preferred
- Bachelor’s degree or equivalent required
- Excellent knowledge of current federal and local regulations on clinical research and GCP
- Demonstrates skills highly adaptable from another cGXP work environments
- Comfortable traveling up to 30% of the time, domestically or internationally (Canada)
- 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.
Benefits
- Health insurance
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Standard Operating Procedures (SOPs)Work InstructionsCorrective and Preventive Action (CAPA)internal study reviewquality reviewsrisk assessmentclinical researchGCP compliancetraining developmentquality investigations
Soft skills
attention to detailcommunication skillsorganizational skillsteam collaborationautonomyrapport buildingadaptabilityproblem-solvingleadershiptraining delivery
Certifications
clinical research certificationBachelor's degree
