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Parexel

Parexel is an international biopharmaceutical services organization offering a comprehensive range of solutions to the biotechnology, pharmaceutical, and medical device industries.

Senior Study Contract Manager - FSP

Location

Netherlands

Posted

4 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglishGoogle Cloud Platform

Job Description

Senior Study Contract Manager - FSP

Parexel

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs. • Develop and negotiate clinical site budgets based on Fair Market Value. • Negotiate agreement language and budget with clinical study sites. • Act as point of contact and interface with Legal if necessary to ensure integrity of contracts. • For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources. • Ensure final contract documents are consistent with agreements reached at negotiations. • Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines. • Support internal and external audits activities. • Ensure compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology and security. • Ensure that all contracts are included in the TMF.

Job Requirements

  • Bachelor degree in related discipline, preferably in life science, law, finance or equivalent qualification.
  • 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.
  • Excellent attention to details.
  • Good written and verbal communication skills.
  • Good collaboration and interpersonal skills.
  • Good negotiation skills.
  • Ability to travel nationally/internationally as required.

Benefits

  • Health insurance
  • 401(k) plan
  • Paid time off
  • Flexible work arrangements

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