Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Study Contract Manager - Parexel FSP
Job ID R0000041251 , NetherlandsKey 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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