Clinical Site Manager

Our customer, Roche Diagnostics in Rotkreuz, is looking for a motivated and dynamic person asClinical Site Manager (m/f/d), 80-100%Your tasks:Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirementsValidating product performance claimsSupplying data for critical Regulatory submissionsObtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leadersResponsibility for adhering to the policies of the quality system and achieving quality objectives through daily actionsPerforming or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeoutMaintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are metInterfacing with cross functional staff to support post launch activitiesReviewing cases with investigators to resolve discrepanciesEnsuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and Roche policies and proceduresYour Profile:Bachelor’s degree (Masters and PhD acceptable) in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate Minimum 1 year of experience in clinical research or laboratory research or minimum 2 years of prior relevant experience Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (GCP, ICH) Excellent planning, organizing, and interpersonal skillsAbility to work independently, make sound decisions, and to analyze and solve problemsMedical laboratory experience preferredGood therapeutic and protocol knowledge.Computer skills including proficiency in use of MS Office Willingness to travel within Europe (30%)Organizational and problem-solving skillsEffective time and financial management skillsExcellent oral and written communication skills in EnglishYour application:Please apply online. For further information, please contact your Gi Group recruiter, Mrs Susanne Junker (+41 76 335 16 58).