Regulatory and Start Up Specialist - Switzerland
On-siteZug, Zug, Switzerland or Zürich, Zurich, Switzerland
Job Summary
Conduct site activation and maintenance activities for clinical studies in Switzerland, serving as the Single Point of Contact for investigative sites, the Site Activation Manager, and the Project Management team. Prepare regulatory documents, review them for completeness and accuracy, and distribute completed materials to sites and internal team members. Ensure adherence to SOPs, GCP/ICH guidelines, and project timelines while maintaining internal databases and tracking tools. Provide local expertise during project planning, monitor performance metrics, and implement contingency plans as needed. Review and follow up on the approval and execution of documents, including the Informed Consent Form and Investigator Pack. This home-based role requires German fluency and is part of IQVIA's global clinical research services.
Required Qualifications
- German language fluency
- Bachelor's Degree in life sciences or a related field
- 3 years' clinical research or other relevant experience
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of applicable regulatory requirements, including local regulations, SOPs and company's Corporate Standards
- Understanding of regulated clinical trial environment and knowledge of drug development process
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