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Trial Master File Specialist Job in Cincinnati, Ohio US
Monster
 
 
 
 

Job Summary

Company
Medpace, Inc.
Location
Cincinnati, OH
Industries
Government and Military
Job Type
Full Time
Employee
Years of Experience
Less than 1 Year
Job Reference Code
82231218_1

Trial Master File Specialist

About the Job

Trial Master File Specialist


Job Locations

United States-OH-Cincinnati




Category

Site Activation & Maintenance


Job Summary




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 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
May 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 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

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.

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