Contract Specialist - Customer Dedicated (FSP) contract opportunity

United Kingdom
26 Apr 2021
26 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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 process
  • Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations as developed by Contract Manager and approved by Sponsor
  • Ensures compliance of budgetary guidance, templates and process as directed by Investigator Analysts
  • Identifies 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 processes
  • Provides recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels
  • Coordinates 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 activation
  • Achieve PPD's target cycle times for site activations
  • Ensures 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 Experience
  • 2+ years of experience working for a CRO or Biopharma company

  • Bachelor's degree
  • 2 - 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 laws
  • Demonstrated ability to apply basic principles of investigator grant negotiation
  • General understanding of business and financial principles that related to service agreements
  • Effective communication skills(verbal & written) in English and in language spoken at local place of work
  • Capable, with appropriate oversight,of drafting and negotiating contract provisions and budgetary issues within parameters
  • Strong attention to detail
  • Excellent analytical and decision based thinking
  • Understanding of the pharmaceutical product development process and involvement of CROs
  • Able to work independently or in a team environment
  • Good organizational and time management skills
  • Working knowledge of PPD SOP &WPDs
  • Able to organize competing priorities logically and review outstanding contractual risk and issues
  • Able 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

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