Full-Time
Trial Master File Representative
Posted on 12/20/2024
Celerion
1,001-5,000 employees
Clinical research organization for drug development
Junior
No H1B Sponsorship
Remote in UK
This is a remote, home-based position within the UK.
- 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
- responsible for the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies
- responsible for 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
Celerion specializes in early phase drug development as a clinical research organization (CRO). The company provides a range of services to pharmaceutical and biotechnology companies, including clinical trial design, feasibility studies, project management, and regulatory affairs. Celerion uses advanced bioanalytical techniques, particularly High Resolution Mass Spectrometry (HR MS), for metabolite profiling and identification, which enhances their research capabilities. This focus on bioanalytical sciences and their extensive experience allows Celerion to assist clients in making informed decisions during the early stages of drug development. Unlike many competitors, Celerion emphasizes speed and quality in their research processes, aiming to help clients bring new treatments to market more quickly, ultimately benefiting patients around the world.
Company Stage
Acquired
Total Funding
N/A
Headquarters
Lincoln, Nebraska
Founded
2010
6 month growth
↑ 11%1 year growth
↑ 11%2 year growth
↑ 15%
Simplify's Take
What believers are saying
- Celerion's global capabilities support the growing trend of decentralized clinical trials.
- The rise of precision medicine aligns with Celerion's expertise in specialized bioanalytical services.
- Expansion into GLP/GCP compliant testing positions Celerion well in cell and gene therapy markets.
What critics are saying
- Emerging CROs in Asia offer cost-effective solutions, threatening Celerion's market share.
- H.I.G. Capital's acquisition may disrupt client relationships or alter service offerings.
- Regulatory hurdles could delay the rollout of new GLP/GCP compliant testing services.
What makes Celerion unique
- Celerion specializes in early-phase drug development with over 40 years of experience.
- The company excels in metabolite profiling using High Resolution Mass Spectrometry (HR MS).
- Celerion offers comprehensive services including trial design, bioanalytical sciences, and regulatory affairs.
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