IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas
Job Summary
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas.
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
As Regulatory & Start-Up Specialist, you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.
Matching Summary
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas.
Skills & Requirements
Must-have
EU CTR experience for Germany and Austria
Local language proficiency
Regulatory submissions
Site Activation activities
GCP/ICH guidelines
Nice-to-have
Agile structure
Collaborative culture
Deep therapeutic expertise
Medical device submissions beneficial
Key Requirements
1-3 years clinical research experience in submissions
Experience in EUCTR and CTIS submission procedures
Experience in DACH region feasibility and site contracts