Study Start Up Associate II

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

📋 Description

• Oversee the commencement of clinical trials, ensuring adherence to regulatory standards.

• Play an active role in site start-up and activation processes, assuming responsibility for deliverables and collaborating effectively.

• Direct the preparation and submission of regulatory documents, such as clinical trial applications, ethics committee submissions, and communications with regulatory agencies.

• Coordinate and communicate with both internal and external stakeholders to secure necessary approvals and authorizations for study initiation.

• 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 for study start-up activities.

• Engage in process enhancement initiatives aimed at streamlining study start-up procedures and boosting efficiency.

⛳️ Requirements

• Bachelor's degree in life sciences or a similar field.

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

• Strong comprehension of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulations.

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

• Outstanding communication and interpersonal abilities, with the talent to collaborate effectively within cross-functional teams.

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

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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