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Fortrea

Site Budgeting and Contracting Specialist - FSP

RemoteCanada only
Published
Role
Operations
Experience
Mid
$80k–$89k/yr
Check eligibility

Open to CA only. Set where you work from to check your eligibility.

No BS summary

Home-based USA or Canada specialist with 2+ years of CRO-level site budget and contract negotiation experience. Must have direct site-facing experience and global budget template building experience.

What you'll do

  • Prepare country site budgets and study financial appendices.
  • Assist with the negotiation of site agreement budgets and financial exhibits of a certain complexity.
  • Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets.
  • Ensure CTAs are executed in a timely manner in order to meet expected timelines for study start-up.
  • Liaise with the legal departments to ensure any content changes to the CTAs are mutually agreeable, and in accordance with client's legally approved standard agreement language.
  • Participate in Study kick-off meetings to obtain necessary information required for effective CTA execution.
  • Apply solid understanding of standard contract language to enable decision making pertaining to sections of CTAs when language modifications are proposed by external contract parties.
  • If language is not compliant, discuss issues with legal and work with the legal department, sites, contractors or vendors to resolve them.
  • Generate site budgets based on final approved country budget in preparation for distribution to sites and following up with investigators.
  • Research medical procedure costs using local or global database in order to provide accurate data for development of the site level budgets to allow Country Lead Monitors/Study Managers to calculate the latest average costs on procedures for their new studies.
  • Manage CTAs ensuring all changes to agreements and corresponding components are updated according to client’s legal standards and client Global SOPs.
  • Ensure annual review of all templates with the Legal department and Local Head of Monitoring and Site Management.
  • Manage the contract tracking database, including coordination of timely updates with respect to CTA.
  • Ensure accuracy of information and reconcile discrepancies between documents and the database.
  • Post fully executed contracts in eFiliA and locally on the Clinical Operations secure drive.
  • Process internal approval forms and other documents required to ensure compliance with the Internal Signatory Process and annual audits for each study.
  • Ensure excellent communication and collaboration as point person among clinical trial site personnel, client’s Head, Clinical Operations, Legal Counsel and Manager, Insurance, throughout the contract negotiation process.
  • Prepare for internal audits by maintaining a complete and accurate paper trail for each site contract negotiation.
  • Negotiate Master Services Agreements (MSAs) with Institutions where Clinical Trials have been conducted and ensure they are reviewed prior to their renewal dates.
  • Support Country Study site budget template, parameter, and payment term building to ensure timely setup of individual site budgets.
  • Manage and execute assigned study site budget maintenance activities through life of study.
  • Negotiate directly with globally assigned sites master clinical trial agreements rate cards.
  • Partner with site payment department to ensure site budget and payment terms compatibility with payment systems and EDC requirements.
  • Partner with internal Study Startup team, Clinical Operations teams, and TAU partners to improve overall SB&C metrics and implement processes.
  • Ensure standards are applied to the SB&C processes across projects, portfolios and support continuous improvement activities while developing TA-aligned strategies.
  • Leverage leading industry tools and data sources to provide budget and payment terms feedback aligned with parameters and fair market value guidance.
  • Promptly recognize and improve potential delays and escalate non-performance.

What they require

  • Must have a Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education.
  • Experience in the healthcare field, pharmaceutical industry or clinical research preferred.
  • 2 years of site budget & contract negotiation experience at CRO level.
  • 2+ years of global experience building budget templates.
  • Must be site facing.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Regular and consistent attendance.
  • Varied hours may be required.

Benefits

  • Medical
  • Dental
  • Vision
  • Life
  • STD/LTD
  • 401(K)
  • ESPP
  • Paid time off (PTO) or Flexible time off (FTO)
  • Company bonus where applicable

one of the world´s largest and longest-established early-phase clinical research organizations

HealthcareEnterprisefortrea.com

What people say about this company

2.9/ 5

$80k–$89k/yr