Dienstgeber: Greiner Bio-One GmbH

Standort: Kremsmünster, AT, 4550

Reiseausmaß: keine Reisetätigkeiten

Stellentyp: unbefristet

Arbeitsform: remote

Your challenge

Collaborate with a clinical project team to establish project objectives and timelines for IVD/MD trials
Conduct of IVD and MD studies in accordance with the protocol, standard operating procedures, ISO 14155 & GCP, Regulation (EU) 2017/745 (medical devices), Regulation (EU 2017/746 (IVDs) and Medical Devices Act
Trial sites feasibilities
Performance of site initiations, on-site monitoring, monitoring GBO-lab, remote monitoring and close-out visits
Training of study team members in accordance with protocol specific requirements and (local) regulations
Ensuring the accuracy, validity and completeness of study data
Support the (international) trials submission to authorities and ethics committees
Main contact for study teams and liaison between trial sites and sponsor
Creation of study specific forms
TMF maintenance

Your profile

University degree in biology, medicine, pharmacy or an equivalent combination of education, training and work experience in clinical trials
At least 2 years of experience as a clinical monitor (CRA) in a CRO/medical device or pharmaceutical company
Good knowledge of current industry practices related to the conduct of clinical studies (ICH-GCP, ISO 14155, ISO 20916)
Good knowledge of MDR and IVDR and a good understanding of GDPR
Experience of FDA, ISO regulations and CLSI guidelines is an advantage
Ability to work independently and reliably in a fast-paced and changing environment
Excellent communication skills in business fluent German and good written and spoken English skills are a must
Travelling required

Our offer

We 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. This position can be performed remotely or in the office in Kremsmünster, provided that the distance between your place of residence and Kremsmünster is less than 80 km.

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.

Job ID: 3093

Clinical Monitoring (all genders)