Job Description
We are currently hiring individuals for an exciting career in clinical research managing our Trial Master File. The Trial Master File (TMF) is a collection of documentation that allows the conduct of a clinical trial, and the integrity of the data produced, to be evaluated by regulatory bodies, such as the FDA. The TMF is an important tool and can help teams manage trials more effectively. Therefore, 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 would be working with a highly experienced team of other administrators and clinical research professionals that can help you grow your skillset while working for a growing and developing company. A cover letter is encouraged with application submission and recommended to those with indirect experience.
Responsibilities The TMF Document Administrator supports TMF oversight for a trial by ensuring documents meet established quality standards. This position involves both independent and computer-based work, as well as opportunity for communication and collaboration with trial teams.
- Manage electronic filing system for trial documentation;
- Track, maintain, and perform quality check of electronic documents;
- Communicate with internal associates globally regarding errors in trial documents; and
- Prepare documents for shipment.
Qualifications - High school diploma, or equivalent;
- Some experience in document administration;
- High attention to detail;
- Excellent organizational skills
- Strong written and verbal communication skills; and
- Knowledge of MS Office.
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 - 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
Awards - Named a Top Workplace in 2024 by The Cincinnati Enquirer
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
Job Tags
Permanent employment, Contract work, Local area, Currently hiring, Flexible hours,