Tasks & Responsibilities
* Management of complex, global multi-center IVD and medical device performance studies
* Execution of clinical research projects within a defined timeline and budget
* Coordination of submissions to authorities and ethics committees
* Ensure 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 regulations
* Main contact for study related questions/requirements as part of a cross-functional project team
* Main contact for CROs (Clinical Research Organization), physicians and authorities
* Coordination and support in contract negotiations with clinical trial sites, CROs and vendors
* Creation of study concepts, plans and reports as well as project-related plans such as monitoring plan, project management plan
* Creation of SOPs, forms and other relevant study or process documents
Required Capabilities/Competences
* 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 (CPM) or 5-6 years as Clinical Research Associate (CRA) at 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 is a must
* Knowledge of FDA requirements related to IVDs and MDs, ISO regulations and CLSI guidelines are beneficial
* Good understanding of the GDPR
* Ability to work independently and reliably in managing multiple projects (international) and in a fast-paced and changing environment
* Excellent spoken and written English
* Excellent presentation, communication and diplomacy skills, with the ability to negotiate and resolve conflicts
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.
Profilbeschreibung
Not applicable for interfaces
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