Clinical Research
vor 2 Wochen
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Angesichts unseres dynamischen Geschäftsumfelds und des anhaltenden Erfolgs suchen wir qualifizierte Talente für unsere Medical Affairs Abteilung in Solothurn, um unsere wachsende Nachfrage zu decken und unsere Wettbewerbsposition weiter zu stärken.
Clinical Research & Evaluation Manager80%Your main tasksCollaboration as a Medical Affairs Team member in projects for product development and product maintenance; in this context, planning of clinical documentation relevant for approval, clinical risk managementPerforming the function of Study Manager:Responsible for the management of clinical projects Applicable standards in the field: Create interpretations and gap analyses and ensure complianceApplicable standards in the field: Create interpretations and gap analyses and ensure complianceDeveloping and implementing global clinical research projectsDeveloping and maintaining relationships with local & international opinion leadersMedical-scientific support of the R&D, Marketing & Sales etc.
departmentsTraining & Education activities (internal & external)Creating and updating Clinical Evaluation Reports, PMCF Plan/Reports; ensuring documentation and implementation in accordance with normative requirements; keeping knowledge of requirements up to date independently; creating and maintaining process descriptions and representing them vis-à-vis authoritiesCarrying out literature research and documenting evaluations to answer clinical questions in connection with Ypsomed's products and therapeutic areasPreparing clinical development plans for new products and new indicationsPreparing clinical development plans / clinical evaluation plans and reports, post market clinical follow up plans (and reports) for new products and new indicationsPreparing and maintaining clinical documentation / clinical evaluation plans and reports, post-market clinical follow-up plans and reports for products in the post-marketing phaseCreating GCP-compliant documentation for clinical trialsCreation and revision of training material in Medical Affairs for employees of other departments & Training & Education activities (internal & external)Clarification of medical issuesAuthority:
Intervene in the event of non-compliance with regulatory requirements, if necessary by blocking product batches for further use or placing on the marketEscalation of compliance decisions to QMR and PRRC in case of unresolved disagreements within the business areaYour profileMaster of Science (MSc) degree, in a natural science discipline or health field, or equivalentDoctorate (PhD or Dr.) is an advantage> 2 years of experience in clinical trial planning and monitoring.> 2 years of experience in clinical evaluation of medical devices, orExperience in clinical science, risk analysis and study planning in medtech industry is an advantageVery good knowledge of standard requirements ISO 14155-GCP, MEDDEV 2.7.1 rev.4 and 2017/745 for Medical Devices (MDR)Sound knowledge of clinical research/testing methodologyKnowledge of the medical device industry and strong scientific understanding (experience in medical devices, at least class II)Very good knowledge of standard requirements ISO 14155-GCP, MEDDEV 2.7.1 rev.4 and 2017/745 for Medical Devices (MDR).Sound knowledge of clinical research/testing methodologyFluent in written and spoken English and any other language is an advantageIhre PerspektiveSie finden bei uns interessante Arbeitsinhalte, gute Entwicklungschancen sowie attraktive Anstellungsbedingungen.
Wir bieten Ihnen die Gelegenheit, die innovations- und qualitätsorientierte Welt der Medizintechnik ein Stück weit mitzugestalten.Wir freuen uns auf Ihre Online-Bewerbung mit Angabe Ihrer Verfügbarkeit (Kündigungsfrist) und Ihrer Lohnvorstellung.
Ypsomed AGGregor Stoffel // Human Resources //Telefon // //
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