Job Description

JOB SCOPE

• Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required training and effectively drive timelines aligned with company priority.
• Communicate with sites, Lilly functions, clinical research organization to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
• Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
• Compose initial Informed Consent Form or amendments based on country ICF template as well as response to queries by Ethic Committees
• Coordinate the management and delivery of clinical trial material to ensure support of site initiation.
• Populate internal clinical trial systems (e.g., Vault Clinical, Shared Investigator Platform, IMPACT) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.
• Ensure complete, accurate and readily available Trial Master File.

REQUIREMENT

• At least bachelor\xe2\x80\x99s degree preferably in a scientific or health related field, postgraduate degree is also welcomed.
• 1-4 years clinical research experience or relevant experience preferred.
• Understanding of the overall clinical development paradigm and the importance of efficient site activation.
• Applied knowledge of project management processes and skills.
• Appreciation of / experience in compliance-driven environment.
• Effective communication, negotiation, and problem-solving skills.
• Self-management, able to multitask and good organizational skills.
• Language capabilities \xe2\x80\x93 English (read, write, conversation).1-4 years clinical research experience or relevant experience preferred.

Job Type: Full-time Salary: RM5,200.00 - RM6,500.00 per month Benefits:

• Dental insurance
• Maternity leave

Ability to commute/relocate:

• Kuala Lumpur: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have 1-4 years clinical research experience or relevant experience preferred?
• Do you possess knowledge about the comprehensive process of clinical development and the significance of ensuring a streamlined and efficient site activation within this context?

Language:

• English (Required)