Regulatory and Start Up Specialist(m/w/x)

Anforderungen

• German language fluency
• Submissions experience in Switzerland or Belgium
• Degree in life sciences, related field, or equivalent
• Three years clinical research or relevant experience
• Knowledge of clinical systems and procedures
• Knowledge of corporate standards
• Ability to apply GCP/ICH and regulatory guidelines
• Knowledge of local regulations and SOPs
• Understanding of regulated clinical trial environment
• Knowledge of drug development process

Aufgaben

• Perform country-level Site Activation activities
• Follow local and international regulations
• Adhere to SOPs and contractual guidelines
• Execute ongoing site maintenance activities
• Act as Single Point of Contact for studies
• Liaise with sites and project management teams
• Ensure quality of deliverables and timelines
• Distribute completed documents to project members
• Prepare and review site regulatory documents
• Maintain internal systems and tracking tools
• Provide feedback on site performance metrics
• Establish and agree on project timelines
• Implement monitoring measures and contingency plans
• Communicate completion of regulatory and contractual documents
• Track progress of ethics and ICF documents
• Manage Investigator Pack release documents
• Provide local expertise for project planning
• Perform quality control of site documents
• Communicate directly with sponsors on specific initiatives

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien