Logo for Celerion

Trial Master File Representative (Remote - UK)

Role overview

Qualifications

  • Bachelor's degree in related field such as science or other biomedical discipline
  • Experience in clinical research and/or Trial Master Files preferred
  • Minimum 1 year document management experience
  • Excellent interpersonal and oral/written communication skills

Responsibilities

  • Preparation and completeness of the Trial Master Files for internal and external studies
  • Maintenance of the Trial Master File, creating a file structure and indexing contents
  • Communicate with client Sponsors, Project Managers, monitors, sites, and other study contacts to ensure compliance to protocol and regulatory/local requirements

Key facts

Other skills

  • Microsoft Word
  • Microsoft Excel
  • Microsoft PowerPoint
  • Communication
  • Collaboration

About the company

Celerion logo

Celerion

Contract Research Organizations (CRO)

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com

Company details

Company typeLarge
IndustryContract Research Organizations (CRO)
Company size1001 - 5000

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job description

TMF Representative
 
Join a team that's going places! Every member of Celerion is involved in making a distinctive contribution to the health and well-being of people around the world. That's the sense of purpose shared by our employees. We are a performance-driven drug research company, operating in robust and growing markets. We have an exciting future and offer a competitive salary in a strong developmental environment.
 
Celerion, a leader in the clinical research industry, currently has an opportunity for a TMF Representative to join our team.  This is a remote, home-based position within the UK. Applicants must have full and permanent right to work in the UK, Celerion does not currently offer Sponsorships.
 
In this position, you will be responsible for the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies where Celerion has been contracted for the TMF services to meet Sponsor negotiated specifications. You will be responsible for maintenance of the Trial Master File, creating a file structure and indexing contents. You will also communicate with client Sponsors, Project Managers, monitors, sites and other study contacts to ensure compliance to protocol, and regulatory/local requirements.

Requirements
  • Bachelor's degree in related field such as science or other biomedical discipline
  • Experience in clinical research and/or Trial Master Files preferred
  • Minimum 1 year document management experience.
  • Excellent interpersonal and oral/ written communication skills.
  • Highly organized and collaborative.
  • Proficient computer skills, i.e., MS Word, Excel, PowerPoint.
  • Ability to manage multiple priorities
  • Celerion Values:       Integrity   Trust   Teamwork   Respect
     
    Are you ready to join our team?
     
    Celerion is an Equal Opportunity Employer.

    Apply once. Then go straight to the hiring manager.

    After you apply, unlock the direct contact details of the people who actually make the call. A quick follow-up makes you 5x more likely to land an interview.

    MR

    Marcus Rivera

    Chief Revenue Officer

    m.rivera@company.com
    linkedin.com/in/marcusrivera
    Unlocked after you apply
    Β·

    Related jobs

    Other jobs at Celerion

    Premium

    Reach out to the hiring manager directly.

    Gain access to the contact details of the hiring managers who actually decide, and reach out to network with them directly. That, plus more when you upgrade:

    • Full match report with fit score and gaps
    • Career diagnostics on how recruiters read you
    • Curated company matches and warm intros
    • 48h early access to new roles

    Cancel anytime.