Country Activation and Submission Representative - France

About the role

iQVIA is looking for a Country Activation and Submission Representative based in Paris to carry out country-level Site Activation (SA) activities in line with local and international regulations, standard operating procedures (SOPs), project requirements and budgetary guidelines. The role 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, under general supervision.
• 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, checking 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 planning and timelines.
• Implement contingency plans where needed and inform the team when regulatory and contractual documents are completed for each site.
• 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, perform quality control of site documents, and may have direct contact with sponsors on specific initiatives.

Required profile

• Bachelor's degree in life sciences or a related field.
• 3 years' clinical research or other relevant experience.

Required skills

• In-depth knowledge of clinical systems, procedures and corporate standards.
• Knowledge of GCP/ICH and applicable regulatory guidelines, including local regulations, SOPs and company standards.
• Understanding of the regulated clinical trial environment and the drug development process.