Country Activation & Submission Specialist

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

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