Clinical Project Manager (all genders) Medical Devices / IVDs
Summary:
A highly skilled Clinical Project Manager is required to manage complex, global multi-center IVD and medical device performance studies. The successful candidate will be responsible for the execution of clinical research projects within a defined timeline and budget.
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 an exciting and independent area of responsibility in a modern and collegial working environment. Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.
About Us:
Greiner Bio-One is a place where visionaries come together to shape the future of healthcare. We welcome individuals who share our passion for excellence and strive to make a difference in people's lives.
Benefits:
* Aus- & Weiterbildung
* Altersvorsorge
* Betriebsarzt
* Essenszuschuss
* Gesundheitsmaßnahmen
* Flexible Arbeitszeiten
* Parkplatz
* Kinderbetreuung
* Firmenevents
* Vergünstigungen
* Home Office
* Variable Vergütung
* Jobrad
* Zusatzversicherung
* Verkehrsmittelzuschuss