Site Budgeting and Contracting Specialist

Posted 3 days ago

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Prepare budgets for country sites and document financial appendices.

• Assist in negotiating site agreement budgets and financial exhibits.

• Develop Clinical Trial Agreements (CTAs) utilizing standard templates and Contract Information Sheets.

• Ensure timely execution of CTAs to align with study start-up timelines.

• Collaborate with legal departments to address CTA content modifications and approved language.

• Participate in study kick-off meetings to ensure alignment.

• Review proposed modifications to CTA language and resolve compliance issues with legal teams, sites, contractors, or vendors.

• Generate site budgets based on approved country budgets and follow up with investigators.

• Research costs of medical procedures using local or global databases.

• Manage CTAs, changes in agreements, and related components in accordance with legal standards and Global SOPs.

• Coordinate annual reviews of templates with Legal and site/monitoring management leadership.

• Oversee the contract tracking database and address any discrepancies.

• Upload fully executed contracts into eFiliA and the Clinical Operations secure drive.

• Process internal approval forms and documents to ensure compliance with signatory requirements and annual audits.

• Act as the primary contact among site personnel, clients, Clinical Operations, Legal Counsel, and Insurance/Management during negotiations.

• Maintain thorough and accurate documentation for internal audits.

• Negotiate and review Master Services Agreements with institutions before their renewal.

• Support the development of country study site budget templates, parameters, and payment terms.

• Execute maintenance of site budgets throughout the study lifecycle.

• Negotiate master clinical trial agreement rate cards with globally assigned sites.

• Collaborate with site payment departments to ensure budget and payment-term compatibility with payment systems and EDC requirements.

• Partner with Study Startup, Clinical Operations, and TAU teams to enhance SB&C metrics and processes.

• Apply standards across projects and portfolios and contribute to continuous improvement initiatives.

• Develop strategies aligned with TA and provide feedback on budgets/payment terms using industry tools, data sources, and fair market value guidance.

• Identify potential delays and escalate issues of non-performance.


⛳️ Requirements

• Must be based in the USA or Canada.

• A minimum of 2 years of experience in budget/contract negotiation at the CRO level is required.

• Direct site-facing experience is essential.

• At least 2 years of global experience in building budget templates.

• Experience in the healthcare sector, pharmaceutical industry, or clinical research is preferred.

• A Bachelor's degree or equivalent scientific or commercial higher vocational education is necessary.

• Proficiency in using various computer software, both developed in-house and commercially available.

• Regular and consistent attendance is expected.

• Flexibility in working hours may be required.


🏝️ Benefits

• Medical coverage.

• Dental insurance.

• Vision coverage.

• Life insurance.

• Short-term and long-term disability insurance.

• 401(K) retirement plan.

• Employee Stock Purchase Plan (ESPP).

• Paid time off (PTO) or Flexible time off (FTO).

• Company bonus where applicable.

• Comprehensive benefits for eligible regular, full-time, or part-time employees working 20 or more hours per week.

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