FSP Site Budget & Contracts Specialist

Home Based in USA.

Must have 2+ years of budget/contract negotiation experience at CRO level with direct site facing experience.

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

• Solidunderstandingof standardcontractlanguage toenabledecision makingpertainingtosections of CTAswhen 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 basedonfinal approvedcountrybudgetinpreparation fordistribution tosites andfollowingupwith 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 andclient Global SOPs.

• Responsible to ensureannual reviewofalltemplateswiththeLegal departmentand Local Headof 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 foreachstudy,internalapprovalforms andother documents whichare requiredto ensure compliance with the Internal Signatory Process and are also required for annual audits.

• Ensureexcellentcommunicationandcollaborationas pointpersonamongclinical trial sitepersonnel(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.

• NegotiateMaster Services Agreements(MSAs)with InstitutionswhereClinical Trialshavebeenconductedandensuretheyare reviewed prior to their renewal dates

Education:

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

Experience:

• Experienceinthe healthcare field, pharmaceutical industry or clinical research preferred.