Full-Time
Trial Master File Representative
Celerion
1,001-5,000 employees
Global CRO for early-phase development
No salary listed
Remote in UK
Remote
Bachelor's
 Biology & Biotech (1) |
|---|
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- A bachelor's degree in a related field such as science or another biomedical discipline.
- A minimum of one year of document management experience.
- Excellent interpersonal and oral and written communication skills.
- Highly organized and collaborative.
- Proficient computer skills, including Microsoft Word, Excel, and PowerPoint.
- Ability to manage multiple priorities.
- Prepare and ensure the completeness of Trial Master Files for internal and external studies where the company has been contracted for Trial Master File services, meeting sponsor-negotiated specifications.
- Maintain the Trial Master File, create file structures, and index contents.
- Communicate with client sponsors, project managers, monitors, sites, and other study contacts to ensure compliance with the protocol and regulatory and local requirements.
- Experience in clinical research and/or Trial Master Files.
Celerion is a global contract research organization focused on early-phase drug development. It supports pharmaceutical and biotech clients with trial design, feasibility, project management, clinical and medical monitoring, bioanalytical sciences, and regulatory affairs, all conducted under contract. Its work hinges on metabolite profiling using high-resolution mass spectrometry to inform development decisions. With 40+ years of experience and a global, integrated service network, Celerion aims to help clients bring safe, effective treatments to patients faster by delivering rigorous, timely research.
Company Size
1,001-5,000
Company Stage
Acquired
Total Funding
N/A
Headquarters
Lincoln, Nebraska
Founded
2010
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See people who can refer or advise you
Simplify's Take
What believers are saying
- Zurich capacity expansion on June 25, 2026 directly meets rising bioanalytical demand.
- May 6, 2025 Labnotes upgrade improves sponsor data handling and reporting speed.
- THL’s April 22, 2026 acquisition funds more instrumentation, talent, and global footprint growth.
What critics are saying
- THL’s June 15, 2026 $1.8 billion buyout raises exit pressure and leverage risk.
- Labcorp, ICON, and Parexel keep squeezing pricing on early-phase studies through 2026.
- A failed FDA, CLIA, or CAP inspection in Lincoln or Zurich would shatter sponsor trust.
What makes Celerion unique
- Integrated Phase 1 clinics and bioanalytical labs across Lincoln, Phoenix, Zurich, Belfast.
- June 25, 2026 Zurich expansion strengthens metabolite profiling, immunogenicity, biomarker, and gene therapy analytics.
- Fifty-plus years in early clinical pharmacology gives Celerion credibility with complex first-in-human programs.
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↑ 3%Celerion invests in its site in Fehraltdorf. 30 June 2026 10:05 Supporting partner. Fehraltdorf/Lincoln - Celerion is expanding its lab in Fehraltdorf. In so doing, the company, which is headquartered in the US State of Nebraska, is seeking to respond to increasing global demand for bioanalytical services. The company's Swiss lab supports Celerion's research activities in the UK and USA. (CONNECT) Celerion is expanding its bioanalytical laboratory at the company's Swiss location in Fehraltdorf near to Zurich. As detailed in a statement issued by the company from Lincoln in the US State of Nebraska, this investment will strengthen Celerion's ability to meet the growing worldwide demand for bioanalytical services, in addition to supporting rapid study execution and providing access to specialized scientific expertise across complex drug development programs. The plans involve targeted investments in cutting-edge instrumentation and specialized scientific talent. "This expansion reflects both the growth of the bioanalytical market and the increasing demand we are seeing from our clients worldwide", as Chad Briscoe, Executive Vice President of Global Bioanalytical Services at Celerion, explains in the statement. Celerion's Swiss laboratory is integrated with the clinical research units in the USA and the UK, which is said to facilitate efficient sample management and the rapid delivery of high-quality data. "As therapeutic modalities continue to evolve, our clients need bioanalytical partners that can scale alongside increasingly complex development programs", comments Susan Thornton, who founded Celerion in 2010 and has been leading the company as CEO since then. "This investment ensures we remain well-positioned to deliver the expertise, quality, and responsiveness that help accelerate the development of new medicines". ce/mm
Celerion expands Zurich bioanalytical laboratory to meet growing market demand. LINCOLN, Neb.; June 25, 2026 - Celerion, a global leader in early clinical research and bioanalytical services, today announced the expansion of its bioanalytical laboratory in Zurich, Switzerland. The investment strengthens Celerion's ability to support increasing global demand for bioanalytical services, providing clients with enhanced capacity, rapid study execution, and access to specialized scientific expertise across complex drug development programs. "This expansion reflects both the growth of the bioanalytical market and the increasing demand we are seeing from our clients worldwide," said Chad Briscoe Ph.D., Executive Vice President of Global Bioanalytical Services at Celerion. "By investing in both our people and technology, we are expanding our ability to deliver fast, actionable data while maintaining the scientific rigor and quality that are fundamental to successful drug development." The Zurich laboratory offers a comprehensive range of bioanalytical capabilities, including pharmacokinetic analysis, immunogenicity testing, biomarker assays, biosimilar support, gene therapy analytics, and metabolite profiling. Integrated with Celerion's clinical research units in the United States and United Kingdom, the laboratory enables efficient sample management and rapid delivery of high-quality data to support critical development decisions. The expansion includes targeted investments in advanced instrumentation and specialized scientific talent, increasing operational capacity while maintaining the high standards of quality, accuracy, and responsiveness that clients expect from Celerion. Located in one of Europe's leading life sciences hubs, the Zurich facility serves as a key component of the company's global bioanalytical network. Susan Thornton, Ph.D., Chief Executive Officer of Celerion, added, "As therapeutic modalities continue to evolve, our clients need bioanalytical partners that can scale alongside increasingly complex development programs. This investment ensures we remain well-positioned to deliver the expertise, quality, and responsiveness that help accelerate the development of new medicines." The expanded Zurich laboratory is fully operational and actively supporting new and ongoing clinical and bioanalytical programs, reinforcing Celerion's commitment to advancing drug development through scientific excellence and global collaboration. About Celerion Celerion, a global leader in early clinical research, offers clients expert-driven services that enable fast, informed decisions in drug development. With over 50 years of experience, Celerion specializes in Phase 1 studies, including first-in-human dose escalation, drug-drug interactions, cardiac safety, bioequivalence, metabolism, and pharmacokinetics in patient populations. Celerion also provides comprehensive data management, biostatistics, clinical monitoring, and bioanalytical services. For more information, visit www.celerion.com.
Celerion, a global clinical pharmacology and bioanalytical sciences company, has received a majority investment from private equity firm THL Partners. The deal will support Celerion's expansion of its clinical and bioanalytical capabilities. The investment aims to help Celerion continue its growth and innovation whilst advancing its work with pharmaceutical and biotechnology partners to bring new therapies to patients worldwide. Financial terms of the transaction were not disclosed. THL Partners specialises in middle-market growth companies.
H.I.G. Capital has signed a definitive agreement to sell Celerion Holdings, a global contract research organisation specialising in clinical pharmacology and bioanalytical sciences, to funds affiliated with THL Partners. Financial terms were not disclosed. Headquartered in Lincoln, Nebraska, Celerion provides clinical pharmacology services including first-in-human dose escalation, cardiac safety studies and drug-drug interaction research. The company operates facilities in Lincoln, Phoenix, Zurich and Belfast, serving pharmaceutical and biotechnology clients. H.I.G. acquired Celerion in November 2022 and supported strategic investments across commercial, operational and technology initiatives, including expanding the company's clinical and laboratory footprint. BofA Securities and Lazard Frères served as financial advisers to H.I.G. and Celerion on the transaction.
LINCOLN, Neb.; May 6, 2025 (Business Wire) – Celerion, a global leader in early clinical research and bioanalytical services, announced the launch of the latest version of Labnotes, its cutting-edge bioanalytical electronic laboratory notebook software elevating data handling and analysis capabilities for sponsors. The latest system enhancements streamline laboratory documentation and improve operational efficiency for users. The updated platform also offers advanced tools for handling and organizing large datasets, ensuring faster processing of reports and optimized database queries