Senior Investigator Budgets Analyst (Biotechnology)

Role Summary

Senior Investigator Budgets Analyst (Biotechnology) – Performs clinical trial budget negotiation, analysis, and administration; assists in clinical trial budget template development; and QC reviews.

Responsibilities

• Assist in developing investigator grant budgets according to protocol specifications.
• Negotiate clinical study budgets with investigators or designated site personnel, typically through a CRO adhering to published service levels.
• Review and negotiate investigator-prepared budgets for FMV compliance, with Medical Affairs/IB Manager oversight adhering to published service levels.
• Contribute to timely updates to tracking systems for progress developed for all clinical site and Investigator-Sponsored Trials (ISTs) budgets, issues, and communications with internal and external sources.
• Participate in clinical working group meetings.
• Assist in coordinating IB management meetings, prepare agendas, draft, and finalize minutes, and track action items to completion.
• Assist in the development of management reports to support budgeting and forecasting.
• Perform Medicare coverage analyses.
• Perform final budget quality check (QC) in accordance with established SOPs.
• Assists with various other business needs and projects as required to support the organization.

Qualifications

• Education: BS/BA degree in related discipline with a minimum of five years of related experience; or MS/MA degree with a minimum of three years of related experience; or equivalent combination of education and experience. May require certification in assigned area.
• Experience/The Ideal For Successful Entry Into Job:
  • Experience in developing and/or negotiating clinical trial research budgets and payment terms
  • Experience with administration of site budgets and grants, including independent preparation of clinical trial budgets and/or site payment management
  • Experience with performing clinical trial research budgets and payment terms quality check
  • Experience in research protocol budget analyses
  • Experience in Medicare Coverage Analyses (MCA)
  • Experience in interactions with outside vendors, e.g., CROs and contract labs
  • Strong Excel knowledge required
  • Proficiency in MS Office required and Smartsheet preferred
  • Prior experience in Biotech/Pharmaceutical industry preferred
  • Oncology company experience preferred
• Knowledge/Skills: Ability to perform thorough reviews of budget documents in MS Excel quickly and without errors; strong analytical and business communication skills; knowledge of clinical development process and associated regulations; ability to collaborate with multiple stakeholders and execute clinical trial contracts according to company timelines.

Education

• BS/BA or MS/MA in related discipline with applicable experience as described above.

Additional Requirements

• Travel up to 10% of the time; environment primarily indoors with computer work; essential physical requirements include sitting/standing and typing.