Study Start Up Associate

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

📋 Description

• Lead the initiation of clinical trials while ensuring adherence to regulatory standards.

• Execute site start-up and activation tasks to a high level of quality, collaborating closely with your team and stakeholders.

• Aid in the preparation and submission of regulatory documents, including clinical trial applications and ethics committee submissions.

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

• Keep accurate and current records of regulatory submissions and approvals.

• Assist study teams in developing essential study documents, such as protocols, informed consent forms, and investigator brochures.

• Engage in study start-up meetings and contribute insights on regulatory requirements and timelines.

⛳️ Requirements

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

• Proven experience in clinical research start-up activities, including submissions, contracts, budgets, and site activation.

• Experience with Phase I submissions is strongly preferred.

• Exceptional attention to detail and strong organizational abilities.

• Capability to work independently and handle multiple tasks concurrently in a dynamic environment.

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

🏝️ Benefits

• Competitive base salary along with performance-based incentives.

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

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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