Senior Associate Clinical Contracts & Budgets

NOTE – We have only 0.8 FTE for this position (32 working hours per week).

Provide clinical site contracting services to clinical study teams to support study start up and conduct activities.

• Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving)
• Support site‑related questions regarding invoice preparation with respect to submission of invoices in Amgen Payment System
• Support resolution of contract issues
• Support contracting with local vendors (translation vendors, printing vendors…)
• Maintain contract tracking in appropriate systems
• Manage Confidential Disclosure Agreement process
• Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
• Ensure payments are made in accordance with contracts
• Maintain payment data tracking in appropriate systems
• Responsible for providing information for entry into systems

• Negotiate site contracts using appropriate guidelines and collect necessary signatures for contract execution
• Negotiate site budgets using appropriate guidelines
• Escalate contract and budget issues to the appropriate stakeholders
• Set up financial data, raise purchase orders and handle appropriate entries/requests into relevant financial and payment systems.
• Track contract progression using appropriate systems
• Amend and terminate contracts as necessary throughout the lifecycle of study
• Store and archive contracts and budgets in appropriate systems
• Maintain payment records and provide assistance with audit review records
• Involvement in obtaining legal approval for changes to legal parts in consent documents
• Responsible and/or point‑of‑contact at vendor level for the contracting process for locally outsourced studies
• Responsible for the clinical trials insurance process
• Participate in appropriate site/legal meetings as required to resolve contract issues
• Participate in appropriate site/finance meetings as required to resolve payment issues
• Approve or reject clinical invoices
• Process and track confidential disclosure agreements as appropriate
• Manage contracting process with clinical trial related consulting agreements

• Decision to raise issues and/or involve legal or GCP & GCPM
• Agreement of budgets/milestones and contracts within parameters

• Finalized contracts and budgets
• Executed contracts
• Status reporting and updates
• Payment execution
  
  Confidentiality agreement

• Master’s degree OR Bachelor’s degree

• Relevant work experience in life sciences or medically related field
• Experience in interactions with outside vendors
• Relevant work experience in Legal, Negotiation and/or Finance

• Working effectively in a team/matrix global environment
• Flexibility
• Ability to understand technical, scientific and medical information
• Good organizational, planning and problem‑solving skills
• Dealing with time demands, incomplete information or unexpected events
• Attention to detail
• Written and oral communication in English and Dutch
• Relationship building
• Time management & prioritization
• Working knowledge of ICH Good Clinical Practice (GCP), understanding of drug development process and concepts of clinical research
• Good working knowledge of common software packages (e.g. Office 365, especially Excel, SAP)
• Negotiation skills

Hybrid, at least 2 days in Breda office.