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Clinical Project Manager

Clinical Project Manager

Chemie / Pharma / Biotechnologie
  • Dauerstelle - Vollzeit
  • Référence : INT-022646
  • Partager:

Détails

  • Région Zürcher Unterland / Limmattal
  • Type de contrat Dauerstelle - Vollzeit
  • Secteur d'activité Chemie / Pharma / Biotechnologie

Introduction

For our client, one of the leading manufacturers of cardio- and endovascular implants and catheters in Bülach, we are looking for an individual as

Clinical Project Manager (unlimited contract, full-time).

The earliest start date is as soon as possible or within 6 months.

Description de la mission

  • Conduct and oversight of international clinical studies within agreed timelines and budget
  • Define and author all essential clinical study documentation (e.g. Clinical Study Protocol or Clinical Investigational Report) as required by MEDDEV 2.7.1, MDR 2017/745, ICH-GCP, ISO 14155, FDA, PMDA, and local legal requirements
  • Coordinate and support internal and external interfaces within clinical studies and build up strong relationships with key opinion leaders
  • Execute or coordinate the regulatory submissions to Ethics Committees and Competent Authorities as applicable
  • Assure the handling and reporting of safety information in clinical studies according to regulatory requirements as well as readiness for internal and external audits
  • Be on top of the main literature and competitive environment in the field
  • Oversee the monitoring activities for assigned clinical studies (Site Evaluation, Site Initiations, Site Monitoring, Site Close Out Visits) in collaboration with the monitoring representatives and/or external providers
  • Select and manage external vendors within assigned clinical investigations
  • Collaborate closely with the Clinical Data Management/Statistician for assigned clinical studies
  • Plan and control the budget for assigned clinical studies
  • Prepare abstracts and presentations for congresses
  • Support and review draft publications for peer-reviewed journals


Profil attendu

Your Qualifications:

  • University or bachelor`s degree in science; medical education is an advantage
  • Clinical Project Management experience in international medical devices regulations; basic medical knowledge as well as good knowledge of MEDDEV 2.7.1, MDR 2017/745ISO 14155, CFR and relevant guidelines
  • Literate in Microsoft Office applications
  • Fluency in English and basic German; any additional language is an advantage
  • Team- and customer-oriented, analytical and detail-oriented, flexible and communicative personality with excellent soft skills


Application process
Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application.

Informations

  • Agence GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
  • Publié le 27. Oktober 2021
  • Consultant Marijke van Engelenburg