Senior Study Contract Manager - FSP

Parexel FSP is hiring a Senior Study Contract Manager to join us on a permanent full-time, home-based basis.

The position can be based in the Netherlands or Belgium.

If you’re driven by the potential of science to create meaningful change and eager to explore your capabilities, join us.

Dedicated to a single sponsor in BioPharma, who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. Turkey is a vital part of their global network, hosting colleagues from every segment of the life sciences value chain. Their science-driven approach aims to transform healthcare and improve patient outcomes, while also fulfilling a purpose-led role in society.

The Senior Study Contract Manager (Sr.SCM) plays an important role in driving the costings and contracts being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with Investigators and institutions or external vendors ensuring ethical, fair, and compliant practices. Sr.SCM has regular communication with investigators and institutions as well as other key external and internal stakeholders.

• Adapts global templates of agreements to local use by 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 the integrity of contracts.
• For each agreement, maintain the status of the 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 promptly contributing to efficient site start-up timelines.
• Supports internal and external audit 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).

• At least 2 years of experience in site contract negotiation/customization.
• Experience in negotiating contracts with clinical investigative sites/hospitals.
• 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.
• Experience of Netherlands contracts.
• Desirable - experience with Belgium contracts.

Education:

Bachelor’s degree in a related discipline, preferably in life science, law, finance, or equivalent qualification.

Apply today!