Clinical Associate- TMF/Trial master file/QC review - (Westwood, NJ)

Position title:Associate, TMF Process Management and QC- Direct Hire Position Location-Woodcliff Lake, NJ Position overview: The Associate, 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 assisting with the oversight of the eTMF vendor; performing quality control review of study documents to ensure they adhere to SOPs and meet regulatory requirements 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 Associate, TMF Process Management and QC, will lead initiatives and will serve as a subject matter expert in TMF Process Management. Job Requirements