Country Associate Submissions Representative, France, IQVIA Biotech

Job Summary

The Site Activation Specialist is responsible for coordinating and executing site start-up and activation activities for clinical research studies in accordance with applicable regulations, SOPs, project requirements, and timelines. The role serves as a key point of contact for investigative sites and project teams, ensuring the timely preparation, review, and tracking of regulatory and essential study documents.

Key Responsibilities

• 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.

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.