Study Start Up Associate II

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

📋 Description

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

• Assist in site start-up and activation processes.

• Prepare and submit regulatory documentation, such as clinical trial applications, ethics committee submissions, and communications with regulatory agencies.

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

• Manage and uphold thorough 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.

• Participate in initiatives aimed at process improvement to enhance the efficiency of study start-up operations.

• Function within a sponsor-dedicated model, leveraging ICON’s global expertise.

⛳️ Requirements

• 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.

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

• Exceptional organizational and project management abilities, with a capacity to prioritize and manage multiple tasks concurrently.

• Outstanding communication and interpersonal skills, enabling effective collaboration with 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 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.