Associate Study Manager in Neuchatel

veröffentlicht
Kontakt
Lucie Nasshan, Basel Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
Neuchatel, Neuenburg
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
14982
Kontakt
Lucie Nasshan, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

For an international tobacco company in Neuchâtel, we are seeking a: 

 Associate Study Manager

Location: Neuchâtel

Contract will start beginning of December until 30.11.2021

Your Responsibilities: 

  • Support to Study Managers in managing / execution of the studies and/or coordinate execution of own, assigned studies. For own studies lead of the study team and manage all operational aspects of the study including oversight of the CROs (Clinical Research Organization), investigational sites, labs and other external/internal stakeholders involved in the study execution.

  • Coordinates the preparation and contributes to study related documents (e.g. IB, Study Protocols, Informed Consent Forms, various study plans, diaries, CRF, Study Report, etc.). Ensures timely delivery and contribution / reviews of such documents.

  • Supports monitoring activities including review and contribution to the monitoring plans, review of monitoring reports, follow-up letters and co-monitoring visits.

  • Ensures that studies are executed with full adherence to ICH GCP, Declaration of Helsinki, SOPs and any relevant guidelines and regulations.

  • Ensures timely collection of essential documents and completeness of paper and / or electronic Study Master Files. Contributes to the Quality Control of all deliverables received from CROs, vendors & investigators.

  • Tracks the progress of the assigned studies and ensures their completion according to defined quality, timelines and costs.

  • Supports Study Manager and / or Manager of Study Operations in planning, review and tracking of the study plans, budgets, invoices and change orders.

  • Maintains up-to-date knowledge of ICH GCPs and relevant regulations. Supports Study Operations group in revision/preparation of selected SOPs / WKIs and document templates.

 

Your profile:

  • Scientific background in the life science domain.

  • 1-3 years’ experience in management of clinical studies or clinical trial monitoring in a pharmaceutical company or a CRO

  • Good knowledge of ICH GCP and methodology of execution and monitoring of clinical studies

  • Excellent spoken and written English; additional languages would be an asset

  • Good project management skills including use of tools such as MS Project

  • Good MS Office skills

  • Working knowledge of eTMF system(s) (e.g. Veeva Vault) and Electronic Data Capture Systems (e.g. RAVE)

 

Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position