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

Clinical Trials Quality Manager

ManagerManagerFull TimeRemoteTeam 201-500Since 2018H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

66 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)