Regulatory and Start Up Specialist with Contracts v Praha, Česko
IQVIA
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
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