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IQIQVIA

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

Basel
Full-timeWith Home OfficeExperienced

Country-level site activation and ongoing maintenance for clinical trials at global healthcare intelligence firm. Submissions experience in Switzerland or Belgium required. Single point of contact for studies, 30 days vacation.

Requirements

  • 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

Tasks

  • 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

Work Experience

3 years

Education

Bachelor's degree

Languages

GermanBusiness Fluent

Tools & Technologies

GCPICHSOPs
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