FSP Site Budget & Contracts Specialist

Fortrea•Durham, CA

4d•Remote

About The Position

Fortrea's FSP team is hiring Site Budget & Contracts Specialists! Home Based in USA or Canada. Must have 2+ years of budget/contract negotiation experience at 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, assisting with the negotiation of site agreement budgets and financial exhibits of a certain complexity. Responsibilities include: 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 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. Responsible to 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 for each study, internal approval forms and other documents which are required to ensure compliance with the Internal Signatory Process and are also required for annual audits. Ensure excellent communication and collaboration as point person among clinical trial site personnel (Investigator, Study Coordinator, Institution's Legal Counsel) client’s Head, 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 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.

Requirements

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

Nice To Haves

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 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
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.
Responsible to 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 for each study, internal approval forms and other documents which are required to ensure compliance with the Internal Signatory Process and are also required for annual audits.
Ensure excellent communication and collaboration as point person among clinical trial site personnel (Investigator, Study Coordinator, Institution's Legal Counsel) client’s Head, 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 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.