Clinical Site Manager - Swisslinx

Job description:Contract Details:Start Date: 01.12.2025Duration: Unlimited / open-endedWorkload: 80-100%Location: Rotkreuz, SwitzerlandHome Office: Up to 40%Role Overview:We are looking for a Clinical Site Manager / Clinical Research Associate to coordinate, monitor, and manage in vitro diagnostic clinical studies across Europe. This position ensures studies are conducted according to protocol, regulatory requirements, and quality standards, contributing to product validation and regulatory submissions.Key Responsibilities:Manage all aspects of clinical studies, including site selection, initiation, monitoring, and closeoutEnsure compliance with study protocols, SOPs, GCP, ICH guidelines, and internal policiesLiaise with study investigators, laboratories, and key opinion leadersSupport data collection for regulatory submissions and product validationCollaborate with cross-functional teams to support post-launch activitiesQualifications / Must Haves:Bachelor's degree (Master's/PhD welcome) in Medical Technology, Science, or a relevant fieldMinimum 2 years of experience in clinical or laboratory researchKnowledge of GCP, ICH guidelines, and clinical research regulationsExcellent English communication skills (oral and written)Strong planning, organizational, and problem-solving abilitiesAbility to work independently and travel within Europe (25-30%)Nice to Have:Experience in pathology or IVD studiesWhy Join:Work in a high-impact clinical research environmentCollaborate with top professionals and key opinion leaders in diagnosticsContribute to innovative solutions that improve patient care