We are hiring individuals for a rewarding career in clinical research working in our Trial Master File. The Trial Master File (TMF) is the collection of documentation that allows the conduct of a clinical trial and maintains the integrity of the data produced so it may be evaluated by regulatory bodies, such as the FDA. TMF oversight is important to the successful execution of a trial and ultimately plays a key role in a new drug or device receiving approval. In this position, you would be working with a team of other administrators and TMF specialists 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 Provide guidance and support to study team members and sponsors regarding TMFmanagement;Initiate and manage TMF Specifications based on scope of work, protocol, and other coredocuments 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 andmetric 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; andMay be responsible to other project and responsibilities, as assigned. Qualifications Bachelor's degree;Proficient knowledge of Microsoft® Office and Adobe Acrobat®Computer literacy (i.e., ability to file, scan, create folders, and organize files using varioussoftware);Ability to accurately and carefully follow procedures for completing work tasks; andAbility to perform repetitive work without losing effectiveness/accuracy. Medpace OverviewMedpace 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 OverviewFlexible work environmentCompetitive PTO packages, starting at 20+ daysCompetitive compensation and benefits packageCompany-sponsored employee appreciation eventsEmployee health and wellness initiativesCommunity involvement with local nonprofit organizationsDiscounts on local sports games, fitness gyms and attractionsModern, ecofriendly campus with an on-site fitness centerStructured career paths with opportunities for professional growthDiscounted tuition for UC online programsAwards
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 2024Continually 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