Overview As a Senior CRA, you will lead site monitoring activities to ensure ICH-GCP compliance and data integrity across Switzerland, collaborating with cross-functional teams to support sponsor projects. You assess site processes, manage visits, and drive issue resolution to protect patient safety and study quality. You play a key role in training, audits readiness, and mentor junior staff, contributing to the timely delivery of clinical milestones. This role suits a multilingual, travel-ready professional who helps shape impactful clinical solutions within a supportive, fast-paced environment. Leistungen / Benefits career development opportunities supportive line management technical and therapeutic area training total rewards program inclusive culture cross-functional collaboration Verantwortungsbereiche Perform site qualification, initiation, interim monitoring, management and close-out visits (on-site or remote) ensuring regulatory and protocol compliance Evaluate site performance and escalate issues with action plans to the project team Maintain knowledge of ICH-GCP and applicable regulations and SOPs/processes Verify informed consent documentation and protect subject confidentiality Assess subject safety and data integrity related to protocol deviations and pharmacovigilance Conduct source document review and ensure accuracy of CRF data Resolve data queries and manage IP inventory, labeling, and storage compliance Reconcile ISF with TMF and ensure proper archiving of essential documents Support recruitment, retention, and awareness strategies; enter data into tracking systems Understand project scope, budgets, timelines, and communicate with sites to meet objectives Act as liaison with site personnel and support training; participate in investigator meetings and project staff meetings Provide guidance toward audit readiness and assist with audits and follow-up actions Mentor junior CRAs and participate in clinical operations lead tasks under supervision Zentrale Anforderungen Bachelor in related field or RN; equivalent combination of education, training and experience Knowledge of GCP/ICH guidelines and regulatory requirements Strong monitoring experience in Switzerland Good computer skills and adaptability to new technologies Excellent communication, presentation and interpersonal skills; basic critical thinking Proficient in English; native German with proficiency in Italian or French Ability to travel up to 75% regularly strong communication and interpersonal skills critical thinking adaptability to changing priorities ICH-GCP knowledge GCP/regulatory compliance source data verification
Sr CRA German/French or German/Italian speaking in Burgdorf Arbeitgeber: Syneos Health
Syneos Health ist ein hervorragender Arbeitgeber, der sich leidenschaftlich für die Entwicklung seiner Mitarbeiter einsetzt und eine inklusive Unternehmenskultur fördert, in der jeder authentisch sein kann. Mit einem starken Fokus auf Karriereentwicklung, technische Schulungen und Anerkennung bietet das Unternehmen zahlreiche Möglichkeiten zur persönlichen und beruflichen Entfaltung. In Nordostdeutschland gelegen, profitieren Mitarbeiter von einem dynamischen Arbeitsumfeld, das Innovation und Zusammenarbeit fördert, um gemeinsam bedeutende Fortschritte im Gesundheitswesen zu erzielen.
