Country Activation and Submission Representative - France

IQVIA LLC; Paris; On-site; EUR 55,000 - 75,000; Full time

Job summary

IQVIA LLC in Paris, France seeks a Site Activation Specialist to manage country-level activation tasks in line with GCP/ICH, SOPs and project timelines. You will coordinate with Site Activation Managers, sponsors, and cross-functional teams to ensure regulatory documents are prepared and tracked.

The role requires a life sciences degree and at least 3 years of clinical research experience. You will maintain quality control of documents, support timelines, and provide local regulatory expertise

Qualifications

• Experience applying GCP/ICH and regulatory guidelines.
• Knowledge of local regulations and SOPs in clinical trials.
• Understanding of regulated clinical trial environment and drug development processes.

Responsibilities

• Perform country-level Site Activation tasks per regulations, SOPs and project timelines.
• Serve as SPOC for investigative sites, SAMs, PM teams and other departments.
• Prepare, review and maintain site regulatory documents and IP release documents.
• Ensure accurate completion and maintenance of internal systems, databases and project trackers.
• Provide feedback on site performance metrics and assist in project planning.
• Monitor progress, approvals and execution of regulatory documents within timelines.

Skills

GCP/ICH knowledge

Regulatory guidelines

Education

Bachelor's degree in life sciences

Job description

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. Prepare site regulatory documents, reviewing for completeness and accuracy. Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Review and provide feedback to management on site performance metrics. Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. Inform team members of completion of regulatory and contractual documents for individual sites. Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines. Provide local expertise to SAMs and project team during initial and on-going project timeline planning. Perform quality control of documents provided by sites. May have direct contact with sponsors on specific initiatives.

Qualifications

Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience. In-depth knowledge of clinical systems, procedures, and corporate standards. Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards. Understanding of regulated clinical trial environment and knowledge of drug development process.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.