Job Summary
A healthcare company needs applicants for an opening for a Telecommute Document Management Associate II.
Core Responsibilities of this position include:
- Processing clinical study documentation in accordance with SOPs, OGs, GCP, and ICH guidelines
- Performing quality-control (QC) review of clinical and regulatory documents
- Supporting the inventory and transfer of trial master files to clients at the conclusion of trials
Applicants must meet the following qualifications:
- Bachelor’s Degree required
- In lieu of degree, 4 years' relevant industry-related experience in handling of pharmaceutical/biological regulatory and/or clinical documents or related field
- Two years of demonstrable records management experience, specifically eTMF experience in clinical research field
- Expertise in Microsoft Office Suite and Adobe Acrobat
- Ability to learn and apply SOPs and process governance regulations pertaining to clinical study documentation
