Job Description

This Intern reports to the Clinical Operations Manager and interfaces with the Site Management and Regulatory & Site Activation Team. The intern will be involved in the process of managing clinical trials for novel therapies at the country level.Assignment Scope & Learning Opportunities:(Under the guidance)

• Support of Clinical Trial Assistants (CTAs) and Clinical Research Associates (CRAs) in managing clinical trials
• Update Clinical Trial Management Systems (CTMS) and Trial Master Files (TMFs)
• Data mining and investigator outreach for feasibility studies
• Support the submission of regulatory and ethics submissions of clinical trials
• Clinical Trial Assistant Onboarding Plan (includes: IQVIA in the Clinical Research Industry, Ethics in Clinical Research, Fundamentals of Good Clinical Practice Training & Exam, Regulatory Inspection Readiness, Clinical Trial Management System Training, Introduction to electronic Trial Master File)
• Understanding Site Activation (Includes: The process of starting up a clinical trial in Singapore, Finding the right investigators for a clinical trial in Singapore, Regulatory Documents Collection, Review, Approval and Maintenance)
• Perform tasks assigned by a manager in either the site activation or site management department.

Requirements:

• Final year student in Bachelor of Science in Life Sciences, Pharmaceutical Science, Pharmacy, Bioscience or Healthcare related disciplines preferred.
• Able to commit for full-time internship
• Good interpersonal communication and organizational skills
• Good written and verbal communication skills including good command of English
• Good word processing skills and knowledge of MS Office applications
• Good attention to detail
• General awareness clinical trial environment and drug development process
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors

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