Site Start-Up Specialist based in Switzerland
On-siteZürich, Zurich, Switzerland
Job Summary
Serve as the primary contact for investigative sites during start-up and maintenance activities. Collect, review, and organize essential documents for regulatory submissions, including country-specific application forms and informed consent forms. Ensure compliance with ICH/GCP guidelines and track submission timelines while proactively addressing potential delays. Collaborate with internal and external stakeholders to ensure all documentation is audit-ready and systems are consistently updated. Assist in the negotiation of site contracts and budgets, if applicable. Provide mentorship and training to new hires and less-experienced colleagues. This role is part of the FSPx team working directly with a key sponsor to advance innovative medications.
Required Qualifications
- University/College degree (life sciences preferred) or certification in a related allied health profession
- Minimum 2 years of experience in clinical research, regulatory submissions, or site activation
- Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes
- Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements
- Experience interacting with regulatory authorities and site start-up teams
- Excellent organizational, problem-solving, and communication skills
- Proficiency in Microsoft Office and document management systems
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