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Entry Level Tmf Administrator

Medpace
Medpace
Freshers years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: TMF Document Administrator – Clinical Research
Company: Medpace
Location: Cincinnati, OH


Job Summary
Join Medpace as a TMF Document Administrator and play a pivotal role in clinical research by overseeing the Trial Master File (TMF), a vital collection of documentation that ensures compliance with regulatory standards, including FDA guidelines. Your work will directly support the integrity and successful execution of clinical trials, contributing to the approval of groundbreaking drugs and medical devices. Collaborate with an experienced team, enhance your skillset, and grow within a rapidly expanding organization. A cover letter is encouraged, especially for candidates with transferable skills.


Key Responsibilities

  • Manage and maintain an electronic filing system for trial documentation.
  • Track, organize, and perform quality checks on electronic documents.
  • Collaborate with global associates to address errors in trial documents.
  • Prepare documents for shipment and submission to regulatory bodies.

Qualifications

  • Education: High school diploma or equivalent required.
  • Experience: Previous experience in document administration is preferred.
  • Exceptional attention to detail and organizational skills.
  • Strong written and verbal communication abilities.
  • Proficiency in Microsoft Office Suite (Excel and Outlook).

Why Choose Medpace?

  • Flexible Work Environment: Balance work-life priorities effectively.
  • Comprehensive Benefits: Competitive compensation, starting PTO of 20+ days, and robust health plans.
  • Professional Growth: Structured career paths with ample learning opportunities.
  • Employee Well-Being: Access to wellness initiatives, a modern on-site fitness center, and discounts on local attractions.
  • Community Engagement: Opportunities to support nonprofit organizations and local events.

Cincinnati Campus Highlights

  • Modern, eco-friendly facilities.
  • Exclusive discounts on fitness gyms, sports games, and local attractions.
  • Tuition discounts for University of Cincinnati online programs.

About Medpace
Medpace is a leading clinical contract research organization (CRO) offering comprehensive Phase I-IV development services. Our mission is to advance the development of safe and effective medical therapeutics using a scientific and disciplined approach. Headquartered in Cincinnati, Ohio, we operate in over 40 countries and specialize in therapeutic areas such as oncology, cardiology, metabolic diseases, endocrinology, CNS disorders, and infectious diseases.


Awards & Recognition

  • Named a Top Workplace in 2024 by The Cincinnati Enquirer.
  • Featured on Forbes' list of America's Most Successful Midsize Companies (2021-2024).
  • Honored with CRO Leadership Awards for expertise, quality, and reliability by Life Science Leader.