Entry-Level Trial Master File Specialist
Job Summary
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.
Qualifications
- 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.
Medpace 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.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
- Cincinnati Campus Overview
- Flexible work environment
- Competitive PTO packages, starting at 20+ days
- Competitive compensation and benefits package
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Community involvement with local nonprofit organizations
- Discounts on local sports games, fitness gyms and attractions
- Modern, ecofriendly campus with an on-site fitness center
- Structured career paths with opportunities for professional growth
- Discounted tuition for UC online programs