Clinical Project Manager

Jobangebot - Clinical Project Manager

• Beschäftigungsart:	Senior Professional
  Arbeitgeber:	BIOTRONIK SE & Co. KG Firmenprofil
  Jobdatum:	15. März 2021
  Fachbereiche:	Naturwissenschaften: Pharmazie Sonstige: Humanmedizin
  Einsatzort:	8180 Bülach, Schweiz; Europa-Mitte Map zeigen

  Connecticum Job-Nr. 1373261 / 38442

  Clinical Project Manager BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees. The Medical Affairs Group is responsible for the design, conduction, and evaluation of international first-in-man, regulatory submission, and post-marketing trials. Your Responsibilities Conduct and oversight of international clinical studies within agreed timelines and budget and maintaining regular contacts with investigators Define and author all essential clinical study documentation as required by MEDDEV 2.7.1, MDR 2017/745, ICH-GCP, ISO 14155, FDA, PMDA, and local legal requirements Coordination and support of internal and external interfaces within clinical studies and build up strong relationships with key opinion leaders Execute or coordinate the regulatory submissions to Ethics Committees and Competent Authorities as applicable Assure the handling and reporting of safety information in clinical studies according to regulatory requirements as well as readiness for internal and external audits Being on top of the main literature and competitive environment in the field reviewing study data, coordinating and assuring high data compliance Preparation of clinical study reports for regulatory authorities as well as abstracts and presentations for congresses Support and review draft publications for peer-reviewed journals Your Profile University or bachelor`s degree in science; medical education is an advantage Clinical Project Management experience in international medical devices regulations; basic medical knowledge as well as good knowledge of MEDDEV 2.7.1, MDR 2017/745ISO 14155, CFR and relevant guidelines Literate in Microsoft Office applications Fluency in English and basic German; any additional language is an advantage Team- and customer-oriented, analytical and detail-oriented, flexible and communicative personality with excellent soft skills Are you interested? Please apply via our application management system - thank you. We are looking forward to welcoming you! Location: Bülach, Switzerland | Working hours: Full-time | Type of contract: Unlimited Apply now: www.biotronik.com/careers | Job ID: 38442 Only direct applications will be reviewed and processed. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.