Site Contract Leader (FSP)

Overview:

The Site Contract Leader serves as a legal liaison to process clinical contract requests such as but not limited to, Non-Disclosure Agreements (NDAs), Clinical Trial Agreements (CTAs), Service Agreements, and Ancillary Agreements and supports the management of and negotiate process of site budgets acting as conduit between investigator sites, Clinical Development Operations (CDO) and the Legal group.

Organizational Relationships:Reports to Parexel FSP assigned Line Manager with day-to-day direction from the Client.Liaises with cross functional lines as appropriate.Primary Duties:Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global TrialsServe as legal liaison for clinical contract requests such as, NDA’s, CTAs, Service Agreements, and Ancillary Agreements and act as conduit between CDO and the Legal groupProcess all clinical contract requests and help facilitate early execution through the Contract Management SystemPerform consistent quality audits of work output and document knowledge base as neededMaintain accurate contract metrics on an ongoing basis.Serve as primary contact for the Client during contract negotiation phaseOn-going interface with sites and vendors regarding contractual issues during the lifetime of the contractEstablish and maintain direct site and vendor contactNegotiate Clinical Site Contracts & BudgetsFor Sites Managed by the Client:Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contractWork closely with study teams to develop a budget template tailored for each studyNegotiate and manage consistent site budgets that will assist in early site activationRespond to queries related to contracts and budgetsManage the contract escalation process to appropriate individuals, as neededEstablish good customer relations with sites starting with the primary point of contact for budgets and contractsFor Sites Managed by a Clinical Research Organization (CRO):Review and approve the investigator fee template per country for each study before distribution to sitesBe a conduit for the contract request to the Client Legal team from initial contract request through execution for contracts handled by a CRO and track the contract process for each study with a CRO;Serve as escalation point of contact for budget escalations from CRO;Respond to CRO queries to ensure consistency with contract language and budget line items in accordance with Client standardsAdhere to Clinical Operations or project specific quality documents (e.g. Standard Operating Process (SOPs), work practices, training guides), as applicable.Participate in the development and testing of tools and proceduresComplete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training Adhere to FSP and Client SOPs and processesQualificationsBachelor’s degree in Life Science, Business, Legal or equivalentExperience working in Clinical Site Contract negotiation, proposal development in a biotech or CROIntermediate Excel and database management skillsKnowledge of ICH/GCP in the provision of clinical trialsExcellent negotiation skillsHighly organized with excellent oral and written communication skillsWork both independently and as part of a teamHas a track record of exceeding goals successfullySets objectives to align with broader organizational goalsPartners with others to get work doneFollows through on commitmentsShows personal commitment and takes action to continuously improveDeals constructively with problems that do not have clear solutions or outcomesMaintains a positive attitude despite adversityAcquires data from multiple and diverse sources when solving problems

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