Regulatory and Start Up Specialist - Austria
RemoteAustria
Job Summary
Serve as Single Point of Contact for investigative sites, managing site activation and maintenance activities in accordance with local regulations and SOPs. Prepare and review regulatory documents, including Informed Consent Forms and Investigator Packs, ensuring completeness and accuracy before distribution. Track document progress, approvals, and execution while providing local expertise to the Site Activation Manager and project team during planning. Perform quality control on site-provided documents, maintain internal databases, and review site performance metrics to implement contingency plans as needed. This role requires German language fluency and is based at home.
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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