Regulatory and Start Up Specialist - Belgium
IQVIA
IQVIA seeks a regulatory specialist to manage site activation and country-level regulatory activities for clinical studies in Belgium. The role involves serving as primary contact for investigative sites, ensuring regulatory compliance, and coordinating documentation across project teams.
Responsibilities
- Serve as single point of contact for assigned studies between sites, management, and project teams
- Prepare, review, and distribute site regulatory documents ensuring completeness and accuracy
- Perform site activation activities in compliance with regulations, SOPs, and work instructions
- Track and follow up on regulatory, ethics, ICF, and investigator pack document approvals
- Monitor site performance metrics and implement contingency plans as needed
Requirements
- Fluency in Dutch and/or French language
- Experience with local regulatory submissions and contract negotiations
- Knowledge of site activation procedures and applicable regulations
- Familiarity with standard operating procedures and quality control processes
- Experience with clinical trial regulatory documentation and timelines
L'offre d'emploi a été publiée 1 Il y a un mois
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