Trial Master File Specialist

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. 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. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

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
* May be responsible to other project and responsibilities, as assigned.

Qualifications:

* Bachelor's degree;
* Proficient knowledge of Microsoft(r) Office and Adobe Acrobat(r)
* 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.
			

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