FSP Site Budget & Contracts Specialist

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

Education:

• Must have a Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education

Experience:

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