Regulatory and Start Up Specialist - Romania

About the role

iQVIA is looking for a Regulatory and Start Up Specialist based in Bucharest, working from home. The role covers site activation (SA) activities at country level, in line with local and international regulations, standard operating procedures (SOPs), project requirements and budgetary guidelines, and may also include maintenance activities. It is a home-based position requiring a Romanian speaker.

Key responsibilities

• Serve as Single Point of Contact (SPOC) for assigned studies, acting as Site Activation Manager (SAM) and liaising with the project management team and other departments.
• Ensure adherence to SOPs, work instructions and project timelines, and perform start-up and site activation activities.
• Distribute completed documents to sites and internal team members, and prepare site regulatory documents, checking them for completeness and accuracy.
• Maintain internal systems, databases and tracking tools with project-specific information, and review site performance metrics for management.
• Review, establish and agree on project plans and timelines, set up monitoring measures and implement contingency plans when needed.
• Track and follow up the approval and execution of regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
• Provide local expertise to SAMs and the project team during planning, and quality check documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Required profile

• Home-based role requiring a Romanian speaker.
• Ability to act as SPOC and site activation manager under general supervision.