Regulatory and Start-Up Specialist with Contracts

About the role

IQVIA's Clinical Functional Service Partnership (CFSP) offers a Regulatory and Start-Up Specialist role in Bratislava, working within a sponsor-dedicated environment. You will manage site identification, regulatory submissions (where applicable for the country/region), ethics approvals and site activation, acting as a key liaison between investigative sites, sponsors and internal stakeholders so that studies start faster and comply with local and international requirements.

Key responsibilities

• Serve as the main point of contact for investigative sites, Site Activation Managers, Project Managers and internal stakeholders.
• Execute site identification, feasibility assessment and site activation for assigned clinical studies.
• Prepare, review and distribute regulatory documentation to ensure completeness, accuracy and compliance.
• Track and manage submissions, approvals and execution of documents such as regulatory submissions, ethics committee submissions, informed consent forms, Investigator Pack release documentation and Clinical Trial Agreements.
• Review, negotiate and manage site regulatory documents, contracts and start-up deliverables.
• Maintain accurate records in internal systems, monitor project milestones and identify risks and mitigation plans.
• Provide local regulatory expertise, perform quality reviews of site documentation and review site performance metrics.
• Collaborate with sponsors and cross-functional teams to deliver successful study start-up and site activation.

Required profile

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Experience in clinical trial regulatory affairs, site start-up, site activation or related clinical research functions.
• Strong understanding of local and international regulatory requirements, GCP and clinical research processes.
• Experience managing regulatory documentation, contracts and start-up deliverables.
• Fluency in Slovak or Czech with strong English communication skills.

Required skills

• GCP and clinical research processes
• Regulatory documentation management and contract handling
• Excellent communication, negotiation and problem-solving abilities

The potential base pay range, when annualized, is EUR 30,800 to EUR 46,200, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.