Site Budgeting and Contracting Specialist - FSP

Fortrea•Durham, NC

3d•Remote

About The Position

Fortrea's FSP team is hiring a Budget Builder & Site Contract Specialist. This role is home-based in the USA or Canada and requires at least 2 years of experience in budget/contract negotiation at a CRO level, direct site-facing experience, and experience building global budget templates. As part of a global team, you will be responsible for preparing country site budgets and study financial appendices, and assisting with the negotiation of site agreement budgets and financial exhibits of a certain complexity.

Requirements

2+ years of budget/contract negotiation experience at CRO level
Direct site facing experience
Experience building global budget templates
Solid understanding of standard contract language to enable decision making pertaining to sections of CTAs when language modifications are proposed by external contract parties.
Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education
Experience in the healthcare field, pharmaceutical industry or clinical research preferred.

Responsibilities

Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets.
Ensure CTAs are executed in a timely manner to meet expected timelines for study start-up.
Liaise with legal departments to ensure any content changes to CTAs are mutually agreeable and in accordance with the client's legally approved standard agreement language.
Participate in Study kick-off meetings to obtain necessary information required for effective CTA execution.
Generate site budgets based on the final approved country budget in preparation for distribution to sites and following up with investigators.
Research medical procedure costs using local or global databases to provide accurate data for the development of site-level budgets.
Manage CTAs, ensuring all changes to agreements and corresponding components are updated according to the 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.
Responsible for posting of fully executed contracts in eFiliA and locally on the Clinical Operations secure drive.
Process internal approval forms and other documents required for compliance with the Internal Signatory Process and for annual audits for each study.
Ensure excellent communication and collaboration as the point person among clinical trial site personnel (Investigator, Study Coordinator, Institution's Legal Counsel), client’s Head of Clinical Operations, Legal Counsel, and Manager, Insurance, throughout the contract negotiation process.
Responsible for preparing 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 the life of the study.
Negotiate directly with globally assigned sites master clinical trial agreements rate cards.
Partner with the 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.