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Site Contracts Specialist

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Site Contracts Specialist
 
Responsible for the development, dissemination, negotiation and finalization of confidentiality and clinical trial agreements and related documents in accordance with protocol specifications, applicable guidelines, regulatory requirements and SOPs.
 
Responsibilities:
  • Prepare, negotiate and monitor compliance with, new and amended contracts for assigned sites/countries/projects.
  • Liaise with other departments on requirements for confidentiality and clinical trial agreements between customers and investigative sites.
  • Provide advice regarding contractual expectations and requirements to investigative sites and internal and external customers.
  • Update and maintain contracts information in the Study Management System and/or reporting mechanism, and for ensuring appropriate paper and electronic filing.
  • Compile, analyze and summarize legal and business positions of parties during the negotiation of contracts according to Sponsor/project specifications.
  • Examine contracts and related documents to ensure completeness and accuracy, as well as conformance to applicable laws, rules, precedents, company, customer and third party requirements in collaboration with internal and external experts.
  • Develop and review of contract templates, negotiation parameters and process documents.
  • Provide support to business development on contract aspects for proposals and budgets.
Requirements:
  • 4 year degree or equivalent combination of education and experience
  • Minimum of 2 years of relevant experience in the biotech, pharma, CRO or healthcare industry
  • Phase IV, non-interventional experience strongly preferred
  • Thorough knowledge of ICH/GCP guidelines
  • Strong written and verbal communication skills
  • Proficiency with computer/software systems
  • Strong organizational, time management, interpersonal, listening, conflict management and negotiation skills
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