Study Contract Manager - Parexel FSP
Primary Location: Netherlands, Remote Job ID R0000041251 Category Clinical Trials
About this Role
Key Accountabilities:
Adapts global templates of agreements to local use in accordance with local requirements and SOPs.
Develops and negotiate 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.
For each agreement 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).
Skills:
Excellent attention to details.
Good written and verbal communication skills.
Good collaboration and interpersonal skills.
Good negotiation skills.
Fluent in English and Dutch
Knowledge and Experience:
At lease 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.
Education:
Bachelor’s degree in related discipline, preferably in life science, law, finance, or equivalent qualification.
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