Clinical Project Leader (all gender)
Hamilton Bonaduz AG
CH - Bonaduz, DE
vor 10 Tg.
source : Monster

Hamilton Medical is a dynamic and internationally successful medical device company headquartered in Bonaduz, Switzerland.

At Hamilton Medical, we live for ventilation technology. Technology that helps caregivers improve the lives of their critically ill patients.

We develop Intelligent Ventilation solutions, devices and consumables. To strengthen our multinational team we are looking for a Um unser multinationales Team zu verstärken suchen wir eine / n >

Clinical Project Leader (all gender) Responsibilities : The research and new technology group is respon sible for the design, management and evaluation of regulatory submission and post-

marketing trials as well as investigator initiated studies. We are currently looking for an experienced clinical project leader who will take over the full responsibility of a strategic regulatory approval project and clinical trial.

Project management responsibility for a clinical project targeting an FDA premarket approval (PMA) of a strategic and innovative medical device product Conduction and oversight of a multi-

center (Europe and US) randomized controlled trial within planned timeline and budget Management of a CRO Definition and co-

  • authoring all essential clinical study documentation as required by the FDA and local legal requirements (ethical committees and IRBs) Keeping a close contact with clinical investigators and sites in Europe and US, regularly visiting them (substantial amount of business travel time) Support and review of draft publications for peer reviewed journals Willingness to travel up to 50% of your working time Qualifications : Master or bachelor s degree in science or medicine;
  • At least 10 years of clinical trial experience within the medical device industry and at least 5 years in the role of a clinical project leader Proven successful completion of clinical trial(s) designed to obtain FDA approval of a medical device ( Class III device) Experience in working with and managing CROs Experience in international medical device regulations;
  • relevant guidelines-knowledge of FDA PMA Experience in communicating with regulatory authorities, specifically FDA is a must Fluency in English language is required, any additional language is an advantage These qualifications would give you an advantage : Advanced degree (MD or PhD) Any critical care medicine and clinical environment experience Knowledge of MDR If you are interested in this position, please apply directly online at to the attention of Ms Bianca Casutt, HR Business Partner.

    Your application should include a letter of motivation, a complete CV, degrees, diplomas and reference letters. Please note that we only can consider online-

    applications. Applications posted by mail or transmitted by e-mail will not be considered. Hamilton Medical AG Via Crusch 8, CH-

    7402 Bonaduz +41 58 610 10 20 Hamilton Bonaduz AG >

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