* Collaborate with aclinical 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 trialsites and sponsor
* Creation of study specific forms
* TMF maintenance
Your profile
* University degree in biology, medicine, pharmacy or an equivalent combination of education, trainingand 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 Germanand good written and spoken English skills are a must
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.
Job ID: 3093
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