Trial Master File Specialist

We are currently hiring individuals seeking an exciting career in clinical research, managing our Trial Master File. The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device receiving approval by the FDA. In this position, you will be working with a highly experienced team of administrators, specialists, and clinical research professionals that can help you grow your skillset while working for a growing and developing company. *This position is office-based in Cincinnati, OH. 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
• help with other project and responsibilities, as assigned.

FDA (Food and Drug Administration), Clinical Research, Clinical Trial, Team Lead/Manager, Data Quality, Team Player, Data Collection, People Management, Requirements Management, Metrics, * Bachelor’s 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.

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits *

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events and intramural sports

Cincinnati Headquarters Experience *

• A modern corporate campus designed to support collaboration and productivity
• Multiple on-site dining options in the heart of Madison Square
• Free on-site parking
• Convenient access to on-site 24-7 fitness and wellness facilities

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries. Why Medpace?:

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work *

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence