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.
