Study Start Up Associate II

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

📋 Description

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

• Assist in site initiation and activation processes.

• Draft and submit regulatory paperwork, which includes clinical trial applications, ethics committee requests, and communications with regulatory bodies.

• Collaborate with both internal and external stakeholders to secure approvals and authorizations for the start of studies.

• Organize and maintain documentation of regulatory submissions, approvals, and communications.

• Offer guidance and support to study teams regarding regulatory standards and best practices for study initiation.

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

⛳️ 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 solid understanding of regulatory standards and guidelines for clinical trials, including ICH-GCP and local regulations.

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

• Strong communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams.

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

• Legal authorization to work in Malaysia.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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