Job Description

Location: Petaling Jaya, Selangors:

• 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 studyxe2x80x99s 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 the Clinical Study with close-out activities, including document archiving.
• Support the preparation and management of clinical-regulatory documents, ensuring they meet technical and submission standards for delivery to relevant authorities. Assist in preparing regulatory submissions in line with the required guidelines.
• Maintain tracking systems for study progress and materials, ensuring accurate and up-to-date information is captured. Assist in the preparation of study-related contracts, payments, and administrative tasks as needed.
• Lead the logistical arrangements and contribute to the organization of internal and external study meetings, such as investigator or monitor meetings. Prepare and distribute relevant materials, ensuring proper communication with all stakeholders.
• Ensure adherence to company policies, local legislation, and ethical standards related to safety, health, security, and other regulatory requirements throughout the study process.

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 in 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 detail, and multitask.

Others Information:For those who have what it takes, please send in resume to:Consultant : Janice Lim
Email:Agensi Pekerjaan & Perundingcara Bright Prospect Sdn BhdNo. 18, 2nd Floor, Jalan 14/14,
46100 Petaling Jaya,
Selangor
Tel : +603-7954 8440

Bright Prospect