Celerion

Celerion

Global CRO for early-phase development

Clinical Data Manager - External Site Studies

Full-Time
No salary listed
Junior, Mid
Bachelor's
Remote in USA
Remote

About the job

Requirements
  • A bachelor's degree in Business, Science, or a related field, or a combination of education and relevant internal Celerion experience in lieu of the degree, is required.
  • One to three years of industry experience is required.
  • Knowledge of Good Clinical Data Management Practices, medical terminology, Good Clinical Practice, International Council for Harmonisation guidelines, and 21 CFR Part 11 is preferred.
  • Knowledge of SAS and Veeva EDC is preferred.
  • Ability to manage multiple projects and priorities is required.
  • High attention to detail is required.
  • Excellent oral and written communication skills are required.
  • Excellent organizational skills are required.
  • Proficiency in Microsoft Office applications is required.
Responsibilities
  • Deliver comprehensive data management services across all study phases.
  • Independently own assigned data management studies and deliverables from startup through database lock, proactively identifying risks, resolving issues, communicating status, and escalating when appropriate.
  • Ensure clinical databases are complete, accurate, and compliant with Sponsor and regulatory standards.
  • Serve as the primary Sponsor contact for data management activities.
  • Lead data management communications and coordinate with internal and external teams to ensure timely delivery of study milestones and progress updates.
  • Train site staff, including clinical research coordinators, clinical research associates, and principal investigators, and client teams on electronic data capture systems.
  • Oversee the case report form lifecycle from design to final delivery.
  • Conduct User Acceptance Testing and ensure database setup aligns with specifications.
  • Develop and manage essential study documents, including the Data Management Plan, Case Report Form Completion Guidelines, Validation Plans, and Serious Adverse Event Reconciliation Plans.
  • Review and clean clinical data, manage queries, and reconcile third-party data.
  • Coordinate database lock and final data delivery.
  • Identify risks and proactively resolve project issues.
  • Provide service to internal and external stakeholders.
Desired Qualifications
  • Knowledge of Good Clinical Data Management Practices, medical terminology, Good Clinical Practice, International Council for Harmonisation guidelines, and 21 CFR Part 11.
  • Knowledge of SAS.
  • Knowledge of Veeva EDC.

About the company

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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Simplify's Take

What believers are saying

  • THL bought Celerion for $1.8 billion in June 2026, validating demand.
  • Zurich lab expansion in June 2026 added capacity for rising bioanalytical demand.
  • Labnotes 2025 improved reporting and database workflows, strengthening sponsor-facing productivity.

What critics are saying

  • Private-equity ownership after THL's June 2026 closing demands aggressive EBITDA growth and exits.
  • Large CROs like IQVIA and Labcorp can undercut pricing in Phase 1 and bioanalysis.
  • A quality failure in CLIA/CAP-regulated labs would damage trust and halt studies.

What makes Celerion unique

  • Celerion combines Phase 1 clinics with bioanalytical labs across Nebraska, Phoenix, Zurich, and Belfast.
  • Its Zurich and Lincoln labs specialize in metabolite profiling, pharmacokinetics, immunogenicity, and gene-therapy analytics.
  • Labnotes and integrated sample handling speed sponsor decisions across complex early-development programs.

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Benefits

Flexible Work Hours

Growth & Insights and Company News

Headcount

6 month growth

↑ 0%

1 year growth

↑ 0%

2 year growth

↑ 4%
Swisstrade
Jun 30th, 2026
Celerion invests in its site in Fehraltdorf.

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
Jun 25th, 2026
Celerion expands Zurich bioanalytical laboratory to meet growing market demand.

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.

Legal Desire
Jun 15th, 2026
THL Partners takes majority stake in clinical pharmacology leader Celerion

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.

PR Newswire
Apr 22nd, 2026
H.I.G. Capital sells clinical research firm Celerion to THL Partners

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.

PharmiWeb
May 7th, 2025
Celerion Launches Enhanced Version Of Labnotes Bioanalytical Data Management Software

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