Clinical Contracts Specialist, Breda, Noord-Brabant

The Company 
The company is a global biotechnology company dedicated to improving the lives of patients. In Breda they focus on preparing, planning, and coordinating the shipping and distribution of clinical trial materials. 

Role Description
The Clinical Contracts Specialist is responsible for delivering end-to-end clinical site contracting and budget support for clinical studies in the Netherlands. The role supports study start-up and ongoing study conduct by ensuring that clinical trial agreements, budgets, and related financial processes are executed accurately, compliantly, and on time. This role operates in close collaboration with cross-functional stakeholders including Clinical Operations, Legal, Finance, GCP/GCPM, and external clinical sites and vendors. 

Responsibilities

• Managing the full lifecycle of clinical site contracts and clinical trial–related consulting agreements, including drafting, negotiation, amendment, termination, execution, translation, distribution, archiving, and issue resolution.
• Negotiating site budgets and milestones in line with applicable guidelines and agreed parameters.
• Acting as a key point of contact for sites on contract- and payment-related questions, including invoice preparation and submission via the Amgen Payment System.
• Ensuring payments are processed in accordance with contractual terms and maintain accurate payment tracking and financial records.
• Setting up and maintaining financial data, raising purchase orders, and completing required entries in relevant finance and payment systems (e.g., SAP).
• Maintaining accurate contract, budget, and payment tracking in designated systems and supporting audit readiness.
• Managing the Confidential Disclosure Agreement (CDA) process, including tracking and execution.
• Supporting contracting with local vendors (e.g., translation, printing) and acting as vendor-level point of contact for locally outsourced studies.
• Coordinating contract escalations and engage Legal, GCP, or GCPM as appropriate to resolve complex issues.
• Participating in site, legal, and finance meetings to address contracting or payment challenges.
• Supporting legal review and approval processes for changes to legal sections of informed consent documents.
• Managing the clinical trial insurance process at the local level.
• Identifying and implement best practices with local and regional partners to improve operational efficiency and effectiveness. 

Requirements

• Master’s degree or Bachelor’s degree.
• Relevant professional experience within life sciences or a medically related field.
• Experience working with external vendors and clinical sites.
• Demonstrated experience in contract negotiation, legal processes, finance, or a related discipline.
• Proven ability to operate effectively in a global, matrixed organization.
• Strong negotiation skills and sound judgment within defined parameters.
• Solid understanding of ICH-GCP, the drug development lifecycle, and clinical research principles.
• Ability to comprehend and work with technical, scientific, and medical information.
• High attention to detail with strong organizational, planning, and problem-solving capabilities.
• Ability to manage competing priorities, tight timelines, and incomplete or evolving information.
• Strong relationship-building skills with internal and external stakeholders.
• Excellent written and verbal communication skills in English and Dutch.
• Proficiency in common business systems and tools, particularly Office 365 (Excel) and SAP.
• Effective time management and prioritization skills in a regulated environment. 

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