Industrial Maintenance and Operations Assessor
Bureau Veritas Group
Manager, Clinical Assessment Technologies Operations
Worldwide Clinical Trials
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Coordinate completeness of rater experience qualification documents and communicating collection results to the Sponsor and study team
- Develop study specific rater training web portals and ensure readiness based on study timelines
- Coordinate logistical matters of the Investigators’ Meetings and associated CAT materials
- Organize the timely completion of editing / formatting of didactic training presentations
- Oversee scale and study source workbook management by obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals
- Oversee data surveillance methodology maintenance by tracking and reconciling incoming source documentation and provide reports to the study team and Sponsor
- Provide necessary CAT data to ensure comprehensiveness of CAT’s Final Study Report
- Oversee archiving of all CAT study documents
- Consulted on rater training and data surveillance plans to ensure documents represent sponsor and protocol specifications
Requirements
- Bachelor’s degree, in Life Science preferred
- Two to four years of experience working in clinical trials
- At least two years of experience managing team members or leading a team
- Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials
- Ample knowledge of SOPs and ICH/GCP/regulatory guidelines
- Fluency in English (will be required to write, speak, and understand English to conduct day-to-day business)
Benefits
- Professional development opportunities
- Flexible working hours
- Health insurance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data surveillance methodologystudy specific training developmentediting and formatting presentationsscale and study source workbook managementregulatory authorizationssource documentation trackingreport generation
Soft skills
team managementcommunicationorganizational skillscoordination
