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Clinical Study Manager

vor 1 Monat

Wien, Wien, Österreich Greiner Vollzeit

Job Overview

We are seeking an experienced Clinical Study Manager to join our team at Greiner. The successful candidate will be responsible for managing complex clinical trials and ensuring the delivery of high-quality results.

About the Role

  • Manage global multi-center IVD and medical device performance studies
  • Execute clinical research projects within defined timelines and budgets
  • Coordinate submissions to authorities and ethics committees
  • Evaluate compliance with quality standards and regulations, including ISO 14155, ISO 20916, ICH-GCP, Regulation (EU) 2017/745, and Regulation (EU) 2017/746
  • Main contact for study-related questions and requirements within a cross-functional project team
  • Coordinate contract negotiations with clinical trial sites, CROs, and vendors
  • Create study concepts, plans, reports, and project management documents

Requirements

  • Degree in life sciences or equivalent combination of education, training, and work experience in clinical trials
  • At least 3 years of experience as a Clinical Project Manager or 5-6 years as a Clinical Research Associate
  • Knowledge of current industry practices related to clinical studies, including ICH-GCP, ISO 14155, and ISO 20916
  • Good understanding of MDR and IVDR
  • Excellent communication and negotiation skills

What We Offer

An exciting opportunity to work on complex clinical trials in a fast-paced environment. Depending on qualifications and experience, the salary may range from EUR 63,596.32 to EUR 80,000 per year, according to the collective agreement for the chemical industry.