Cincinnati, Ohio28 days ago
Responsibilities : 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. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.