Full-Time
Scoping and Budgeting Specialist
Clinical Research
Confirmed live in the last 24 hours
Celerion
1,001-5,000 employees
Clinical research organization for drug development
Mid, Senior
Lincoln, NE, USA + 2 more
More locations: Remote in USA | Phoenix, AZ, USA
Position can be located in Phoenix, AZ or Lincoln, NE, or 100% remote.
- Ability to quickly identify key proposal and budgeting parameters based on knowledge and experience
- Ability to prioritize workflow quickly and efficiently against deadlines
- Strong verbal and written communication skills
- Adept at cross-functional team collaboration, including the ability to interact with all levels of the organization
- Development of early-phase clinical research budgets through the following:
- Evaluation of RFPs for technical specifications, deliverables, roles and responsibilities, deadlines, assumptions, and format requirements
- Review of early phase clinical research protocols to identify key service requirements and assumptions needed for budget
- Consultation with internal subject matter experts to determine project-specific requirements and pricing structure for non-standard activities
- Communication and Coordination of all required third-party vendors and subcontractors throughout the scoping and budgeting process
- Development of comprehensive, accurate, and timely project-specific budgets using an Excel-based tool
- Accurately defining and mapping budgets to sponsor format templates or grids
- Modifying or re-bidding of all budget revisions
- Participation in bid defense meetings, project scoping calls, and ad hoc budget review calls with sponsor and internal teams
- Responding to sponsor questions regarding proposed budget and operational strategy via written and verbal communications
- Generation and submission of project-specific documents to legal department as well as managing the budget through the entire contracting process
- Hosting project alignment and hand-off calls to operational managers
- BA/BS in business/finance/life sciences or equivalent education and experience
- 3-5 years of experience in early phase clinical research
- 3-5 years of experience reading, reviewing, and understanding information contained within clinical research protocols
- Previous experience with clinical trial proposal processes and budget generation
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
↑ 4%1 year growth
↑ 4%2 year growth
↑ 4%
Simplify's Take
What believers are saying
- Rising demand for early-phase trials due to personalized medicine boosts Celerion's market.
- Advancements in AI enhance Celerion's bioanalytical data analysis and metabolite profiling.
- Expansion into cell and gene therapy markets aligns with Celerion's service offerings.
What critics are saying
- Emerging CROs offering similar services at lower costs threaten Celerion's market share.
- Regulatory changes in the EU and China could increase compliance costs for Celerion.
- Talent shortages in the pharmaceutical sector may hinder Celerion's ability to retain staff.
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's global operations offer comprehensive services from trial design to regulatory affairs.
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Benefits
Flexible Work Hours