Clinical Project Manager

We are seeking an experienced Clinical Project Manager to lead global multi-center IVD and medical device performance studies. As a key member of our team, you will be responsible for managing complex projects, coordinating submissions to authorities, and ensuring compliance with high-quality standards.

• 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

We are looking for a highly skilled and experienced Clinical Project Manager with a degree in life sciences or equivalent combination of education, training, and work experience in clinical trials. A minimum of 3 years of experience as a Clinical Project Manager or 5-6 years as a Clinical Research Associate at a CRO/medical device or pharmaceutical company is required.

You should have good knowledge of current industry practices related to the conduct of clinical studies (ICH-GCP, ISO 14155, ISO 20916) and MDR and IVDR. Knowledge of FDA requirements related to IVDs and MDs, ISO regulations, and CLSI guidelines is beneficial. Excellent spoken and written English, presentation, communication, and diplomacy skills, with the ability to negotiate and resolve conflicts, are also essential.

• An exciting and independent area of responsibility in a modern and collegial working environment
• A competitive salary of approximately €63,596.32 per year, depending on qualifications and professional experience
• A range of benefits, including Aus-& Weiterbildung, Altersvorsorge, Betriebsarzt, Essenszuschuss, Gesundheitsmaßnahmen, Flexible Arbeitszeiten, Parkplatz, Kinderbetreuung, Firmenevents, Vergünstigungen, Home Office, Variable Vergütung, Jobrad, Zusatzversicherung, Verkehrsmittelzuschuss

Greiner Bio-One is a leading manufacturer of medical devices and IVD products. We offer a dynamic and innovative work environment that encourages creativity, teamwork, and continuous learning. If you are a motivated and ambitious individual who wants to make a difference in the healthcare industry, we encourage you to apply.