Cincinnati, OH30+ days ago
Provide guidance and support to study team members and sponsors regarding TMF management; Initiate and manage TMF Specifications based on scope of work, protocol, and other core documents working with functional area leads and sponsor contacts; Set up and maintain study specific TMF folder structure; Support CTMs with review of TMF Plans as required; Support study team(s) during periodic TMF QCs by assisting with report development and metric reporting; Report on TMF Health to Sponsors and CTMs; Contribute to audit/inspection readiness activities by reviewing the TMF, TMF Specifications, and TMF Plans for accuracy, consistency, and completeness; Train and mentor other TMF staff; and help with other project and responsibilities, as assigned. Bachelors degree, life science field preferred Proficient knowledge of Microsoft Office and Adobe Acrobat Computer literacy (i.e., ability to file, scan, create folders, and organize files using various software); Ability to accurately and carefully follow procedures for completing work tasks; and Ability to perform repetitive work without losing effectiveness/accuracy.