Clinical Study Support Specialist (MNC)

Location: Petaling Jaya, Selangor

Job Descriptions:

• Assist with the coordination and management of clinical studies from initiation to close-out, ensuring smooth execution at all stages.
• Collaborate with investigators, service providers, and clinical research associates for efficient document collection and submission processes.
• Collect, review, and track necessary documents for clinical study applications.
• Ensure timely submission to the boards and authorities as required, maintaining compliance throughout the study’s duration.
• Oversee the setup, maintenance, and tracking of essential documents in electronic systems, ensuring compliance with relevant guidelines and regulatory standards.
• Ensure proper preparation and timely upload of study documents to maintain inspection readiness. Contribute to the finalization of study files and support clinical study close-out tasks, including archiving document.
• Help prepare and manage clinical and regulatory documents to meet technical and submission standards. Support the creation of regulatory submissions according to required guidelines.
• Keep tracking systems updated with accurate study progress and materials. Assist in the preparation of study-related contracts, payments, and administrative tasks as needed.
• Handle logistics and help organize internal and external study meetings, like investigator or monitor meetings. Prepare and share materials, making sure all stakeholders are well-informed..
• Make sure all study activities follow company policies, local laws, and ethical standards, including safety, health, security, and regulatory requirements.

Job Requirements:

• At least a Bachelor’s Degree in Life Sciences, Biology, Chemistry, Biochemistry or any equivalent qualification.
• Minimum 1 to 2 years of working experience as the clinical administrative role in the medical or any related field.
• Proficiency in computer literacy skills, especially in Microsoft Office Suites.
• Excellent oral and written English communication skills.
• Ability in leadership, interpersonal, and time-management skills.
• Ability to work in a team, attention to details, and multitasks.

Others Information:

For those who have what it takes, please send in resume to:

Consultant in charge: Wei Li
Email: weili@brightprospect.com.my