Clinical ociate- TMF/Trial master file/QC review - (Yonkers, NY)

Position le:Associate, TMF Process Management and QC- Direct Hire Position Location-Woodcliff Lake, NJ Position description: The ociate, TMF Process Management and QC, will be responsible for performing daily support activities ensuring that the Trial Master File (TMF) is compliant and Inspection Ready. The eTMF system has over 1,000 global users, including CROs. Functions include TMF set-up, managing TMF file structures and archiving of Trial Master Files; eTMF query resolution, eTMF user support and training, and isting with the oversight of the eTMF vendor; performing quality control review of study documents to ensure they adhere to SOPs and meet regulatory qualifications and ICH guidelines. This role will be required to work collaboratively across functional areas and contribute to positive team relationships, both locally and globally. The ociate, TMF Process Management and QC, will lead initiatives and will serve as a subject matter expert in TMF Process Management.