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Study Contract Manager

ManagerManagerFull TimeRemoteMid LevelTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

Netherlands

Posted

39 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglishDutchGoogle Cloud Platform

Job Description

Study Contract Manager

Parexel

• Adapts global templates of agreements to local use in accordance with local requirements and SOPs. • Develops and negotiates clinical site budgets based on Fair Market Value. • Negotiates agreement language and budget with clinical study sites. • Acts as point of contact and interface with Legal if necessary to ensure integrity of contracts. • Maintains the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources. • Ensures final contract documents are consistent with agreements reached at negotiations. • Ensures all agreements are executed in a timely manner contributing to efficient site start-up timelines. • Supports internal and external audits activities. • Ensures compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology, and security. • Ensures that all contracts are included in the Trial Master File (TMF).

Job Requirements

  • At least 2-year experience in site contract negotiation/customization.
  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
  • Good knowledge of relevant local regulations.
  • Basic understanding of the drug development process.
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

Benefits

  • Excellent attention to details.
  • Good written and verbal communication skills.
  • Good collaboration and interpersonal skills.
  • Good negotiation skills.
  • Fluent in English and Dutch.

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