TMF ManagerJob LocationsUnited States-OH-CincinnatiCategorySite Activation & MaintenanceJob SummaryWe are currently hiring full-time office based individuals for an exciting career in clinical research managing our Trial Master File in Cincinnati. 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 and ultimately plays a big role in a new drug or device receiving approval by the FDA. In this position, you would be leading a highly experienced team of TMF professionals and working with members of trial teams to drive TMF strategy while ensuring Medpace TMFs are of high quality.ResponsibilitiesThe TMF Manager supports TMF oversight by providing strategic guidance and support regarding TMF processes to Medpace trial teams and sponsors. They ensure consistency across studies/programs, and participate in audits and regulatory inspections.Ensure consistency of TMF across projects and clients;Present on TMF process to clients, auditors, and inspectors; and,Lead and develop team of TMF Associates and Administrators.QualificationsBachelor's degree;A minimum of 5 years of experience working within the TMF;High attention to detail;Excellent organizational skillsStrong written and verbal communication skills; andKnowledge of MS Office.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 PerksCincinnati Campus OverviewHybrid work-from-home options (dependent upon position and level)Competitive PTO packages, starting at 20+ daysFlexible work hoursDiscounted tuition for UC online programsCompany-sponsored employee appreciation eventsEmployee health and wellness initiativesCommunity involvement with local nonprofit organizationsCompetitive compensation and benefits packageStructured career paths with opportunities for professional growthPartnership and discount with onsite childcareDiscounts on local sports games, local fitness gyms and attractionsOfficial Sponsor of FC CincinnatiModern, ecofriendly campus with an on-site fitness center, bar, and restaurantsAwardsRecognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibilityWhat to Expect NextA 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