Your responsibilities

• Act as Vivalyx’s primary operational contact for investigators and study coordinators.
• Prepare, conduct, and document site initiation, interim on-site and remote monitoring, and closeout visits.
• Perform source data review and verification.
• Track study progress enrollment, follow-up visits, data-entry status, queries, protocol deviations and training needs.
• Review and follow up adverse events, adverse device effects, and device deficiencies.
• Maintain the TMF and support database-lock, audit and inspection readiness.
• Proactively identify risks, resolve operational issues, and escalate when needed.
• Collaborate with cross-functional teams, sites, and CROs to ensure successful study delivery across multiple parallel studies.

Qualifications

• 2+ years of CRA experience preferred, including direct on-site monitoring.
• Experience with medical-device clinical investigations is preferred.
• GCP and ISO 14155 experience required.
• Working knowledge of ICH-GCP required.
• Ability to manage multiple studies and priorities independently in a fast-moving startup environment.
• Clear, pragmatic communicator who can work confidently with investigators, coordinators, CROs, and internal stakeholders.
• Willing and able to travel regularly within Europe and to the United States.
• Fluent in English, both written and spoken (German is a strong plus).