Headlands Research

Headlands Research is improving patients’ lives by advancing innovative medical therapies.

Clinical Trials Quality Manager

ManagerManagerFull TimeRemoteTeam 201-500Since 2018H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

67 days ago

Salary

Not specified

Bachelor Degree5 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

• Monitor the quality and consistency of data and clinical operations at network clinical research sites throughout specific locations in the US and Canada. • Create and maintain new Standard Operating Procedures (SOPs) and work instructions in compliance with ICH-GCP and regulations. • Review and edit existing SOPs for compliance and conformity to network standards. • Support development and delivery of network and site-level training events. • Conduct consistent internal study review activities to ensure compliance with applicable regulations. • Prepare and deliver official reports detailing internal study review activities performed. • Work with operations team to remediate any issues identified at the site and implement preventive actions.

Job Requirements

  • Bachelor’s degree or equivalent required
  • Will consider Associates Degree with 5+ years of equivalent experience
  • Certification by a professional clinical research organization preferred
  • 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).
  • 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
  • Proficient computer skills and use of MS Office
  • Comfortable traveling up to 30% of the time, domestically or internationally (Canada)

Benefits

  • Health insurance
  • Professional development opportunities
  • Remote work options
  • Flexible working hours

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