Clinical Project Manager (all genders) Medical Devices / IVDs

at  Greiner

Dienstgeber: Greiner Bio-One GmbH
Standort:Kremsmünster, AT, 4550
Wien, AT, 1100
Mosonmagyaróvár, HU, 9200
Frickenhausen, DE, 72636
Reiseausmaß: 10%
Stellentyp: unbefristet
Arbeitsform: remote

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

• 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