Austria Job Openings
Greiner
Clinical Project Manager (all genders) Medical Devices / IVDs
Kremsmünster
FULL TIME
November 27, 2024
- 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
- 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
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