Clinical Study Assistant

Clinical Trial Associate

• 1 year contract to start with
• 32 hours per week
• 2 days in Breda office

Purpose:
* Provide clinical site contracting services to clinical study teams to support study start up and conduct activities

Responsibilities:
* 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

Key Activities

* 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 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 Making Authority
* Decision to escalate issues and/or involve legal or GCP & GCPM
* Agreement of budgets/ milestones and contracts within parameters

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


Qualifications
* Master's degree OR Bachelor's degree

Experience
* 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

Competencies
* 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 esp. Excel, SAP)
* Negotiation skills

Let op: vacaturefraude

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* Wij zullen nooit via WhatsApp of in een videogesprek vragen om jouw persoonlijke gegevens (zoals een kopie van je ID, bankgegevens of BSN).
* Twijfel je over de echtheid van een vacature of contactpersoon? Neem dan altijd rechtstreeks contact met ons op via de officiële contactgegevens op onze website.

Important: job fraud

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* We will never ask for personal information (such as a copy of your ID, bank details, or social security number) via WhatsApp or during a video call.
* If you're unsure whether a vacancy or contact person is legitimate, please reach out to us directly using the official contact details on our website.