Tasks & ResponsibilitiesManagement of complex, global multi-center IVD and medical device performance studiesExecution of clinical research projects within a defined timeline and budgetCoordination of submissions to authorities and ethics committeesEnsure compliance with high quality standards in accordance to the study protocol, standard operating procedures, ISO 14155, ISO 20916, ICH-GCP, Regulation (EU) 2017/745 (medical devices), Regulation (EU) 2017/746 (IVDs) and other local regulationsMain contact for study related questions/requirements as part of a cross-functional project teamMain contact for CROs (Clinical Research Organization), physicians and authoritiesCoordination and support in contract negotiations with clinical trial sites, CROs and vendorsCreation of study concepts, plans and reports as well as project-related plans such as monitoring plan, project management planCreation of SOPs, forms and other relevant study or process documentsRequired Capabilities/CompetencesDegree in life sciences or equivalent combination of education, training and work experience in clinical trialsAt least 3 years of experience as a Clinical Project Manager (CPM) or 5-6 years as Clinical Research Associate (CRA) at a CRO/medical device or pharmaceutical companyGood knowledge of current industry practices related to the conduct of clinical studies (ICH-GCP, ISO 14155, ISO 20916)Good knowledge of MDR and IVDR is a mustKnowledge of FDA requirements related to IVDs and MDs, ISO regulations and CLSI guidelines are beneficialGood understanding of the GDPRAbility to work independently and reliably in managing multiple projects (international) and in a fast-paced and changing environmentExcellent spoken and written EnglishExcellent presentation, communication and diplomacy skills, with the ability to negotiate and resolve conflictsOur OfferWe offer you an exciting and independent area of responsibility in a modern and collegial working environment. Due to legal requirements in Austria, we are obligated to disclose the minimum gross salary for the position as defined by the collective agreement which amounts to EUR 59.781,96 (collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.Wir bieten gleiche Chancen für alle und sehen Vielfalt als unsere Stärke. Daher begrüßen wir Bewerbungen von allen Menschen – unabhängig von Merkmalen wie Geschlecht, Alter, Hintergrund, sozialem Status, sexueller Orientierung, Religion sowie geistigen und körperlichen Fähigkeiten. Es ist unser Ziel, Frauen im Unternehmen zu stärken und den Anteil an weiblichen Führungskräften zu erhöhen. Wir fördern eine inklusive Arbeitsumgebung und ermutigen alle Personen, sich zu bewerben.