Remote Site Activation Coordinator (Regulatory)

IQVIA; Courbevoie; Sur place; EUR 42 000 - 64 000; Plein temps

Résumé du poste

IQVIA is seeking a Country Associate Submissions Representative (Regulatory & Start-Up Specialist) for a homebased role in France. The Site Activation Specialist coordinates site start-up and activation activities, ensuring regulatory and ethics documents are prepared, reviewed, and tracked on schedule.

The role acts as the main contact for investigative sites and project teams, ensuring compliance with GCP and regulatory requirements while maintaining project information in internal systems.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, or a related field.
• Minimum 1 year of clinical research experience.
• Knowledge of contract amendments and updating of ICFs beneficial.
• Knowledge of clinical research regulations, Good Clinical Practice (GCP), and site activation processes.
• Strong organizational, communication, and relationship management skills.
• Ability to manage multiple priorities and meet project deadlines.

Responsabilités

• Act as the primary contact for assigned investigative sites and project stakeholders during site activation activities.
• Perform site start-up and activation activities in compliance with applicable regulations, SOPs, and work instructions.
• Prepare, review, and maintain site regulatory documentation, ensuring accuracy and completeness.
• Track approvals and execution of regulatory, ethics, informed consent, and study-related documents to meet project timelines.
• Maintain project information in internal systems, databases, and tracking tools.
• Monitor site performance metrics and provide updates to management and project teams.
• Support project planning, timeline management, and implementation of contingency plans when required.
• Perform quality control reviews of site documentation.
• Provide local regulatory and site activation expertise to project teams and stakeholders.

Connaissances

GCP knowledge

Regulatory/site activation knowledge

Project coordination

Communication skills

Time management

Formation

Bachelor's degree in Life Sciences, Health Sciences, or a related field

Description du poste

IQVIA is seeking a Country Associate Submissions Representative (Regulatory & Start-Up Specialist) for a homebased role in France. The Site Activation Specialist coordinates site start-up and activation activities, ensuring regulatory and ethics documents are prepared, reviewed, and tracked on schedule.

The role acts as the main contact for investigative sites and project teams, ensuring compliance with GCP and regulatory requirements while maintaining project information in internal systems.