Entry-Level Trial Master File (TMF) Specialist

About the Role

We are currently hiring entry-level individuals seeking an exciting career in clinical research, managing our Trial Master File (TMF). The TMF is a collection of documents that stores all data and research collected on a given trial, ensuring data integrity. It is an integral tool that helps teams manage trials more effectively and plays a big role in a new drug or device receiving approval by the FDA. In this position, you will work with a highly experienced team of administrators, specialists, and clinical research professionals to grow your skillset at 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.
• Assist with other projects and responsibilities, as assigned.

Requirements

• Bachelor’s degree (life science field preferred).
• Proficient knowledge of Microsoft® Office and Adobe Acrobat®.
• Computer literacy (e.g., ability to file, scan, create folders, and organize files using various software).
• Ability to accurately and carefully follow procedures for completing work tasks.
• Ability to perform repetitive work without losing effectiveness or accuracy.

About the Company

Medpace is a full-service clinical contract research organization (CRO) providing 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across 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.

Benefits

• Competitive compensation programs that recognize and reward performance.
• Comprehensive health, wellness, retirement, and PTO benefits.
• Office-based culture with occasional work-from-home flexibility for eligible positions after training.
• Company-sponsored social events and intramural sports.
• Modern corporate campus with multiple on-site dining options, free parking, and 24/7 fitness and wellness facilities.

Growth & Development

• 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.