Telecommuting Clinical Study Lead Document Management Associate

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Posted: Friday, March 09, 2018

Job Category: Business Operations, Quality Assurance, Research

Telecommute Level: 100% Telecommute

Travel Requirements: No Travel

Weekly Hours: Full Time

Employment Status: Permanent

Employer Type: Employer

Career Level: Experienced

Job Summary

A pharmaceutical company is searching for a person to fill their position for a Telecommuting Clinical Study Lead Document Management Associate.

Must be able to:

  • Attend and support file audits and liaise with Quality Assurance (QA) to resolve audit findings as appropriate
  • Support the set-up, maintenance, and closure of Trial Master File (TMF) repositories
  • Process clinical study documentation in accordance with SOPs, OGs, GCP, and ICH guidelines

Must meet the following requirements for consideration:

  • Expertise in Microsoft Office Suite and Adobe Acrobat
  • Six years of demonstrable records management experience, specifically eTMF experience in clinical research field
  • Ability to learn and apply SOPs and process governance regulations pertaining to clinical study documentation