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Remote Trial Master File Jobs in Ohio (NOW HIRING)

Trial Master File Specialist

Cincinnati, OH · On-site +1

$32.25 - $44/hr

The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is ...

Entry-Level TMF Administrator

Cincinnati, OH · On-site +1

$32.25 - $44/hr

The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is ...

File legal documents in state and federal courts, including electronic filings, ensuring compliance ... This position requires regular and predictable in-office attendance; remote or hybrid work is not ...

Litigation Paralegal

Beachwood, OH · On-site +1

$30 - $45/hr

Possibility of temp-to-hire and remote work. Responsibilities: * Document drafting and management ... Trial preparation: * Help prepare for hearings and trials by organizing exhibits, coordinating ...

Litigation Paralegal

Beachwood, OH · On-site +1

$30 - $45/hr

Possibility of temp-to-hire and remote work. Responsibilities: * Document drafting and management ... Trial preparation: * Help prepare for hearings and trials by organizing exhibits, coordinating ...

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Remote Trial Master File information

What are the key skills and qualifications needed to thrive as a Remote Trial Master File (TMF) Specialist, and why are they important?

To thrive as a Remote Trial Master File (TMF) Specialist, you need a solid understanding of clinical trial processes, regulatory requirements (such as ICH-GCP), and experience with TMF management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management software, and compliance tracking tools is typically required. Attention to detail, organizational skills, and strong communication are vital soft skills to ensure accurate documentation and effective collaboration across remote teams. These skills and qualifications are crucial for maintaining regulatory compliance, ensuring data integrity, and supporting the smooth conduct of clinical trials.

What is the difference between Remote Trial Master File vs Clinical Trial Associate?

AspectRemote Trial Master FileClinical Trial Associate
CredentialsTypically requires knowledge of GCP, ICH guidelines, and document managementRequires knowledge of clinical trial processes, GCP, and data entry
Work EnvironmentRemote, document management systems, cloud-based platformsOffice or site-based, assisting with trial coordination and data collection
Industry UsageUsed across pharmaceutical, biotech, and CROs for document oversightCommonly employed in clinical research teams for trial support

The Remote Trial Master File focuses on managing and maintaining essential trial documents remotely, ensuring compliance and accessibility. In contrast, a Clinical Trial Associate supports trial activities on-site or remotely, handling data collection and coordination. Both roles are vital in clinical research but differ mainly in scope and responsibilities.

What are the main challenges of managing a Trial Master File (TMF) remotely, and how can they be addressed?

Managing a TMF remotely often presents challenges such as maintaining document version control, ensuring regulatory compliance, and facilitating timely collaboration across dispersed teams. To address these, many organizations utilize secure cloud-based eTMF systems that allow real-time access and updates, implement clear document management protocols, and schedule regular virtual check-ins with team members. Strong communication skills and familiarity with electronic documentation tools are essential for success in this remote environment.

What is a Remote Trial Master File (TMF) and what does the role involve?

A Remote Trial Master File (TMF) professional is responsible for managing and maintaining essential documents related to clinical trials in a digital or remote environment. This role ensures that all regulatory and compliance requirements are met by organizing, tracking, and archiving important trial documentation. Working remotely, TMF specialists collaborate with clinical research teams, auditors, and regulatory authorities to ensure data integrity and readiness for inspections. The job often involves using specialized electronic TMF (eTMF) systems to facilitate secure access and management of files from different locations.
What cities in Ohio are hiring for Remote Trial Master File jobs? Cities in Ohio with the most Remote Trial Master File job openings:

Trial Master File Specialist

Medpace, Inc.

Cincinnati, OH • On-site, Remote

$32.25 - $44/hr

Other

Medical, Retirement, PTO

Re-posted 5 days ago


Medpace rating

8.6

Company rating: 8.6 out of 10

Based on 12 frontline employees who took The Breakroom Quiz

14th of 72 rated research


Job description

Job Summary

We are currently hiring individuals seeking an exciting career in clinical research, managing our Trial Master File. The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool and helps teams manage trials more effectively. 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 will be working with a highly experienced team of administrators, specialists, and clinical research professionals that can help you grow your skillset while working for a growing and developing company. *This position is office-based in Cincinnati, OH. 

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
  • help with other project and responsibilities, as assigned.
Qualifications
  • Bachelor's degree, life science field preferred
  • 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) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

    • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

    • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
    • Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

    • Office based environment with on-site mentors
    • Defined career paths with clear advancement opportunities
    • Industry renowned onboarding and training programs designed to accelerate professional development
    • Ongoing training and continuous learning opportunities throughout your career
    • An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

    • Competitive compensation programs that recognize and reward performance
    • Comprehensive health, wellness, retirement, and PTO benefits
    • Office based culture with occasional WFH that provides flexibility for eligible positions after training
    • Company-sponsored social events and intramural sports

Cincinnati Headquarters Experience

    • A modern corporate campus designed to support collaboration and productivity
    • Multiple on-site dining options in the heart of Madison Square
    • Free on-site parking
    • Convenient access to on-site 24-7 fitness and wellness facilities

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.

Employment Type: OTHER

What Medpace employees say

Pay

Benefits

Hours and flexibility

Workplace

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About Medpace

Sourced by ZipRecruiter

Medpace is a globally recognized clinicial contract research organization (CRO) based in Cincinnati, OH, in the United States. Established in 1992, it operates in the healthcare sector, providing scientifically-driven outsourcing solutions for the development of drugs and medical devices. It offers comprehensive services like full-service clinical development services, regulatory affairs management, clinical pharmacology, data management, statistical analysis, and medical writing. By applying a scientifically-driven, therapeutically-focused, and patient-centric approach, Medpace's mission is to accelerate the global development of safe and effective medical therapies.

Industry

Medical equipment and supplies manufacturing

Company size

1,001 - 5,000 Employees

Headquarters location

Cincinnati, OH, US

Year founded

1992