Regulatory and Start Up Specialist with Contracts v Praha, Česko

IQVIA seeks a Regulatory and Start-Up Specialist to manage site identification, regulatory submissions, ethics approvals, and study activation for clinical trials. The role involves serving as a liaison between investigative sites, sponsors, and internal teams to ensure regulatory compliance and efficient trial initiation.

Responsibilities

• Serve as primary contact for investigative sites, activation managers, and project teams
• Execute site identification, feasibility assessment, and activation activities
• Prepare, review, and distribute regulatory documentation for accuracy and compliance
• Track and manage submissions, approvals, and execution of essential study documents
• Review, negotiate, and manage site contracts and regulatory documents

Requirements

• Bachelor's degree in Life Sciences or related scientific discipline
• Experience in clinical trial regulatory affairs, site start-up, or site activation
• Strong knowledge of local and international regulatory requirements and GCP
• Proficiency managing regulatory documentation, contracts, and start-up deliverables
• Excellent communication, negotiation, and problem-solving skills
• Fluency in local language and English