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Contract Specialist - United Kingdom

Pharmaceutical Product Development (PPD)

United Kingdom

Position Summary

Manages the preparation, negotiation and finalization of “Investigator Contracts” (including, contractual terms and conditions, associated investigator grant budget(s), payment schedule terms and conditions and ancillary documents) with an assigned workload of sites. Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with PPD contractual considerations, client contractual considerations, established process with sites and follows established escalation routes. Liaises and establishes effective relationships with sites and internal PPD functional teams, as directed by Contract and Country Managers. Ensures quality, objectivity and risk analysis in the efficient delivery of Investigator Contracts.Essential Functions

Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted processEnsures compliance to established negotiation parameters, authority approval, contractual process and client expectations as developed by Contract Manager and approved by SponsorEnsures compliance of budgetary guidance, templates and process as directed by Investigator AnalystsIdentifies and assesses legal,financial and operational risks in accordance with PPD and client contractual considerations, and escalates to appropriate level of the organization per established processesProvides recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channelsCoordinates with internal functional departments to ensure various site start-up activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activationAchieve PPD’s target cycle times for site activationsEnsures guidelines and processes are followed for efficient escalation of out of parameter issues to the Investigator Analyst or Contract Manager role, as applicable.Completes tracking and reporting as required Position Summary

Manages the preparation, negotiation and finalization of “Investigator Contracts” (including, contractual terms and conditions, associated investigator grant budget(s), payment schedule terms and conditions and ancillary documents) with an assigned workload of sites. Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with PPD contractual considerations, client contractual considerations, established process with sites and follows established escalation routes. Liaises and establishes effective relationships with sites and internal PPD functional teams, as directed by Contract and Country Managers. Ensures quality, objectivity and risk analysis in the efficient delivery of Investigator Contracts.Essential Functions

Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted processEnsures compliance to established negotiation parameters, authority approval, contractual process and client expectations as developed by Contract Manager and approved by SponsorEnsures compliance of budgetary guidance, templates and process as directed by Investigator AnalystsIdentifies and assesses legal,financial and operational risks in accordance with PPD and client contractual considerations, and escalates to appropriate level of the organization per established processesProvides recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channelsCoordinates with internal functional departments to ensure various site start-up activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activationAchieve PPD’s target cycle times for site activationsEnsures guidelines and processes are followed for efficient escalation of out of parameter issues to the Investigator Analyst or Contract Manager role, as applicable.Completes tracking and reporting as required Minimum Required Education and Experience2 years of experience working for a CRO or Biopharma company

Bachelor's degree2 - 5 years of experience or equivalent combination of education, training, & experience.Required Knowledge, Skills and Abilities

Understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp lawsDemonstrated ability to apply basic principles of investigator grant negotiationGeneral understanding of business and financial principles that related to service agreementsEffective communication skills(verbal & written) in English and in language spoken at local place of workCapable, with appropriate oversight,of drafting and negotiating contract provisions and budgetary issues within parametersStrong attention to detailExcellent analytical and decision based thinkingUnderstanding of the pharmaceutical product development process and involvement of CROsAble to work independently or in a team environmentGood organizational and time management skillsWorking knowledge of PPD SOP &WPDsAble to organize competing priorities logically and review outstanding contractual risk and issuesAble to effectively use automated systems and computerized applications, such as, Microsoft Outlook, Excel, Word, etc.Ability to demonstrate a customer focused style of communication, problem solving and collaboration

Minimum Required Education and Experience2 years of experience working for a CRO or Biopharma company

Bachelor's degree2 - 5 years of experience or equivalent combination of education, training, & experience.Required Knowledge, Skills and Abilities

Understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp lawsDemonstrated ability to apply basic principles of investigator grant negotiationGeneral understanding of business and financial principles that related to service agreementsEffective communication skills(verbal & written) in English and in language spoken at local place of workCapable, with appropriate oversight,of drafting and negotiating contract provisions and budgetary issues within parametersStrong attention to detailExcellent analytical and decision based thinkingUnderstanding of the pharmaceutical product development process and involvement of CROsAble to work independently or in a team environmentGood organizational and time management skillsWorking knowledge of PPD SOP &WPDsAble to organize competing priorities logically and review outstanding contractual risk and issuesAble to effectively use automated systems and computerized applications, such as, Microsoft Outlook, Excel, Word, etc.Ability to demonstrate a customer focused style of communication, problem solving and collaboration

Job posted: 2020-08-25