Danaher Corporation Senior Clinical Research Manager in Kloten, Switzerland
Danaher Company Description
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.
The role is about the direction, design, implementation, monitoring, and reporting of clinical research/trials with focus on External/Internal Studies. Compiling of business and product relevant scientific data/literature incl. writing of reports * To manage clinical investigations according to current standards and to coordinate clinical research projects in the assigned regions. This implies the design of investigation plans, preparation of case record forms and contacts with Ethics Committees and authorities * To record the data from case record forms, review the study material, and visit participating clinics for monitoring * To analyze and statistically process the obtained data and to present the obtained results in reports, as well as, to participate in the preparation of scientific articles * Contribute to the reviewing and updating of all procedures within the department. * Compile Clinical Evaluation plans and reports * Represent Clinical Department in the product development process * Participate in Study Evaluation Team meetings to assist in the evaluation of new study proposals * To participate in Advisory Board Meetings, Congresses, national and international * Searching/ identifying/compiling of business and product relevant scientific literature incl. writing of reports * Participate in reviewing of marketing material with respect to clinical data. * Identifying/selecting investigators who will be responsible for the conduct of the study at the investigator's site. * Responsible for the budget, site selection, resource planning and trial submission process of international studies in the specific area
* indepth knowledge in medicine or, preferrably, in dentistry (MD, DMD, PhD or equivalent) * indepth knowledge in clinical research/investigation methodology * English fluent written and spoken, any other language is an advantage * experience in medical device field of at least 5 years (preferrably dentistry) * Good understanding of questions regarding dentistry * Several years of experience of clinical research processes * Well trained in ICH-GCP (Good clinical practice for clinical studies) * Profound knowledge in ISO14155 (Investigations with medical devices) * Good knowledge in Medical Device Directives as well as local Medical Devices Acts * Good knowledge in statistical methods (parametric as well as non-parametric)
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Nobel Biocare
Job Function: Science
Primary Location: EMEA-Western Europe-Switzerland-Zurich-Kloten
Req ID: NOB002303