The Document Management Associate (DMA) is responsible for the set-up, maintenance, review, and archival of the trial master file (TMF) including quality assessments thereof, and tracking and reporting of key performance indicators. The DMA is a member of one/multiple project team(s) and is responsible for ensuring an audit-ready TMF.
3.1 Education - An Associate’s or Bachelor’s Degree is preferred but not required.
3.2 Training - On the job or professional training in critical document review required. Demonstrated understanding of the TMF Reference Model filing structure, and clinical electronic document management systems.
3.3 Certification – None required. Veeva Vault Administrator Certification preferred.
3.4 Experience - Three (3) years industry experience with at least two (2) years of experience working directly with clinical trial documentation. Experience with Veeva Vault, or other EDMS systems strongly preferred. The ideal candidate has excellent organizational and time management skills and attention to detail, with an ability to maintain productivity and quality in a time-sensitive regulated environment. Must possess strong computer acumen & proficiency with Microsoft Office Suite and familiarity with clinical trial applications. Must possess knowledge of and demonstrate ability to apply pertinent applicable regulations and guidelines including Good Documentation Practice and Good Clinical Practice.
Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.