Regulatory and Start Up Specialist - Spain

About the role

iQVIA is looking for a Regulatory and Start Up Specialist based in Madrid, Spain. The role performs country-level tasks related to site activation (SA) activities in line with local and/or international regulations, standard operating procedures (SOPs), project requirements and budgetary guidelines, and may also include maintenance activities.

Key responsibilities

• Serve as Single Point of Contact (SPOC) for assigned studies with investigative sites, the Site Activation Manager, the project management team and other departments as needed.
• Ensure adherence to SOPs, work instructions, quality of deliverables and project timelines.
• Carry out start-up and site activation activities according to regulations, SOPs and work instructions, and distribute completed documents to sites and the project team.
• Prepare site regulatory documents and review them for completeness and accuracy.
• Maintain internal systems, databases and tracking tools with project-specific information.
• Review and give feedback to management on site performance metrics, and review, establish and agree on project plans and timelines.
• Implement contingency plans where needed and inform team members when regulatory and contractual documents for each site are complete.
• 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 Site Activation Managers and the project team during planning, and perform quality control of documents provided by sites; may have direct contact with sponsors on specific initiatives.

Required profile

• 1 year of clinical research experience.