Our client, DESCRIPTION OF CLIENT AND ROLE.
- Management of the archives of the Clinical Development Department
- Re-organise current archived documents
- Maintain a tracking tool for essential documents availability
- Ensure correct documentation is filed, initially and in an ongoing basis, in accordance with GCP and company SOPs
- Ensure printing and assembly of documents from the TMF for distribution to sites
- Liaise with CRAs to obtain essential documents from study sites
- In conjunction with study team members, establish and maintain GCP archiving as appropriate
- Organization and distribution, as directed, of the following documents: study protocols, patient information leaflet, patient consent form, investigation brochure and case report form.
- Involved in the review and collection of essential documents required for clinical studies such as the informed consent, investigators brochures, Investigator site file, data management plan, etc.
- Co-ordinate and track the distribution of all trial documents e.g. protocol, IB, etc.
- Track invoices and assist in the maintenance and reporting of study related costs and expenditures.
- University degree or equivalent in health sciences, nursing or pharmacy or related field
- Knowledge of ICH GCP
- Previous experience in a GCP environment (ideally previous work experience in a pharmaceutical company)
- Excellent organisational skills
- Attentive to detail
- Ability to multi-task and stay focused on priorities, strong analytical skills
- Work in a team and independently
- Excellent time management
- Very good command of English, computer literate
- Swiss resident or EU citizenship
If you match the above skill set I look forward to receiving your application, including a motivational letter, via this website.
Please check that your qualifications and experience match the vacancy and that you fill the required criteria. After you have submitted this application form with a current CV, we will endeavour to contact you as soon as we can.
Please submit your CV in Microsoft Word format. We are unable to accept CVs submitted in alternative formats.
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