Clinical Trial Assistant
Pharming Group
Leiden
5 dagen geleden

Areas of Responsibility

  • Set-up, organize, and maintain clinical study documentation (e.g. Trial Master File documents, clinical study site documents, email correspondence, training materials, etc.
  • including preparation for internal / external audits, final reconciliation and archival.

  • Collaborates in the development of study documents and reports (e.g., study protocol, IB, ICF(s), CSR, periodic safety reports, etc.
  • including final quality check, editing, and linking of references, to ensure proper formatting and accuracy of the content.

  • Contact clinical sites for specific requests (e.g., enrollment updates, collection of essential documents, meeting arrangements, etc.).
  • Provides scheduled and ad-hoc reports to provide status on study progress.
  • Collect, review and track documents for CA / RA and EC / IRB submissions to confirm the applications are complete before submission and track submissions and approvals for accurate filing in the TMF.
  • Prepare, ship and manage inventory of study related materials and supplies or coordinate the activities with the vendors, as applicable (e.
  • g. CRFs, diary cards, ISF binders, etc.).

  • Liaise with applicable vendor and clinical trial sites to coordinate lab supply shipments, blood sample shipment from sites to the central lab, study medication shipment, etc.
  • Review Investigator / Site invoices and reconcile against the case report forms (CRFs) and budget to ensure to ensure invoices are accurate and processed under the correct billing codes.
  • Collaborate with the legal department to coordinate the review and finalization of site, vendor, and consultant contracts, and ensure invoices are processed correctly.
  • Schedule and attend internal and external project team meetings, and generate agenda, meeting minutes, power point slides, as needed for project, and / or departmental presentations.
  • Assist with the organization of international meetings (e.g. Monitor and Investigator meetings), including selecting and organizing locations at home or abroad, accommodation, transport, facilities, etc.
  • What you'll need to succeed

    A degree in pharma, life sciences, or related

    At least 2 years of experience as Clinical Trial Assistant in a clinical research environment

    Experience with eTMF is a must; preferably with Veeva Vault.

    We expect you to be available for at least 4days / week; fulltime availability is preferred. Due to the global scope of our clinical trials, it is important to be a bit flexible in your working hours.

    What you'll get in return

    We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including :

  • A highly competitive salary
  • 8.33% holiday allowance
  • 30 vacation days
  • An excellent pension plan
  • Commuting allowance
  • You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs.

    Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all Pharmers .

    Also important! We truly value a healthy life-work balance with a lot of flexibility.

    And when you are at our Leiden Headquarters, you have the opportunity to have a fabulous lunch in our subsidized staff restaurant.

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