Study Start-up Associate II

This is a fully remote position, open to applicants in France.

📋 Description

• Assist in the initiation and activation of sites, ensuring accountability for your deliverables while collaborating effectively.

• Oversee the preparation and submission of regulatory documents, including applications for clinical trials, submissions to ethics committees, and communications with regulatory agencies.

• Coordinate and engage with both internal and external stakeholders to secure necessary approvals and authorizations for the commencement of studies.

• Manage and uphold comprehensive and precise records of regulatory submissions, approvals, and correspondence.

• Offer guidance and support to study teams regarding regulatory requirements and best practices related to study initiation activities.

• Engage in initiatives aimed at improving processes to enhance the efficiency of study start-up activities.

⛳️ Requirements

• A Bachelor's degree in life sciences or a related discipline.

• At least 2 years of experience in clinical research or regulatory affairs, specifically in study start-up activities.

• A robust understanding of regulatory requirements and guidelines pertinent to clinical trials, including ICH-GCP and local regulations.

• Exceptional organizational and project management skills, with the capacity to prioritize and handle multiple tasks simultaneously.

• Outstanding communication and interpersonal abilities, enabling effective collaboration with cross-functional teams.

• Willingness to travel as necessary (approximately 5%).

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.