Trial Capabilities (MNC Pharma)

RM 5,000 - RM 7,000 / Per Mon

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Job Description

To collect and submit regulatory documents to the 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 a company priority
To ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out
Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
To obtain clinical trial authorizations and ethical approvals, execution of the budget and contract, records management, and site training
Provide feedback and shared learning for continuous improvement

Requirements

Bachelor’s degree, preferably in a scientific or health-related field
At least 3 years of clinical trial/trial capabilities experience or relevant experience preferred
Applicant with the understanding of the overall clinical development paradigm and the importance of efficient site activation
Applicant with knowledge of project management processes and skills
Applicants with experience in compliance-driven environment is good
Excellent English language skills (comprehension, speaking, reading, and writing)
Effective communication and problem-solving skills
Good organization and time management skills