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Senior Site Management Specialist

vor 2 Wochen

Genf, Genf, Schweiz Anteris Technologies Ltd. Vollzeit

At Anteris Technologies Ltd., we strive to deliver clinically superior solutions that revolutionize patient care and outcomes.

The Senior Clinical Research Associate will oversee the operational aspects of a global pivotal trial across Europe, ensuring seamless execution, timely completion, and regulatory compliance.

Responsibilities:

  • Coordinate study start-up and conduct activities, collaborating with CROs and vendors.
  • Analyze and resolve discrepancies in study documentation, applying GCP principles and regulatory standards.
  • Ensure Good Documentation Practices, internal SOPs, and regulatory compliance through regular audits.
  • Train site personnel and vendors on sponsor and regulatory requirements for study conduct.
  • Verify trial data, maintaining regulatory documents and auditing site and vendor compliance.

Requirements:

  • Bachelor's Degree in a related field with 5+ years of experience in field monitoring required.
  • Medical device experience required; experience with Class III cardiovascular devices preferred.
  • Strong communication, presentation, and analytical skills required.
  • Proven expertise in MS Office suite and good understanding of GCP and regulatory requirements.
  • Clinical research certification preferred and ability to travel up to 50% required.
  • Fluency in English and additional EU languages a plus.