Clinical Contracts Analyst (CCA) or Senior CCA - FSP

Parexel International Corporation

Multiple Locations

Position Purpose:

The Clinical Contract Analyst serves as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements (CTAs), Ancillary Services Agreements, Consultant Agreements and other clinical contracts.

Primary Duties: Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global trialsServe as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements, Ancillary Services Agreements, Consultant Agreements and other clinical contractsProcess all clinical contract requests and help facilitate early execution through the Contract Management SystemServe as primary contact for the Client during contract negotiation phasePerform consistent quality audits of work output and document knowledge base as neededMaintain contract tracking on SharePoint site and other systems used to manage contract and budget files

Negotiate Clinical Site Contracts & Budgets For Sites Managed by Sponsor: Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contractWork closely with study teams to develop country budget templates tailored for each studyNegotiate and manage consistent site budgets that will assist in early site activationEnsure consistency in site payment schedules and terms to facilitate the payment systemRespond 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 contractsAnalyze contract trends using available tools and assist with developing team metrics with regard to contract timelines.

For Sites Managed by a Clinical Research Organization (CRO):Review and approve the master Investigator Fee template developed by CRO for each study before distribution to sitesManage the final execution of site clinical 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;Provide contract/budget comments to CRO on an as needed basis;Respond to CRO queries for previously negotiated site contracts to ensure consistency with contract language and budget line items

Skills and Education: Bachelor’s degree in Life Science, Business or equivalent. MBA preferredMinimum four (4) years of global experience working in a biotech or CRO, finance and/or business environment as a contract analyst/specialistExperience negotiating contract payment terms and budgetsIntermediate Excel and database management skillsKnowledge of GCP/ICH requirementsExcellent analytical and problem solving skillsRequires effective organizational and communication skillsWork both independently and ability to successfully work in a “virtual” team environmentHas a track record of exceeding goals successfullyPartners 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


2022-08-16 00:05:19


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