Clinical Quality & Risk Leader for Trials & Compliance

Novo Nordisk; Kuala Lumpur; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading healthcare company in Kuala Lumpur is seeking a Clinical Quality & Risk Manager to oversee quality assurance and risk management in clinical trials. This pivotal role ensures compliance with regulations while safeguarding participant safety and ensuring data integrity. The ideal candidate will have a Bachelor's degree in Life Sciences, over 5 years of experience in clinical operations, and a strong grasp of GCP and regulatory guidelines. Join our innovative team to drive excellence in clinical development and tackle serious chronic diseases.

Qualifications

• 5+ years of relevant experience in clinical operations or quality role in the pharmaceutical industry or CRO.
• Demonstrated ability to ensure high-quality execution of clinical trial activities.
• Broad understanding of clinical R&D and global regulations.

Responsibilities

• Oversee quality assurance and risk management activities for clinical trials.
• Perform ongoing quality risk assessments and develop mitigation plans.
• Identify risks using analytics and digital tools.

Skills

Quality assurance

Risk management

Data analysis

Regulatory compliance

Clinical operations

Education

Bachelor's degree in Life Sciences or related field

Master's degree preferred

Job description

A leading healthcare company in Kuala Lumpur is seeking a Clinical Quality & Risk Manager to oversee quality assurance and risk management in clinical trials. This pivotal role ensures compliance with regulations while safeguarding participant safety and ensuring data integrity. The ideal candidate will have a Bachelor's degree in Life Sciences, over 5 years of experience in clinical operations, and a strong grasp of GCP and regulatory guidelines. Join our innovative team to drive excellence in clinical development and tackle serious chronic diseases.