Clinical Quality & Risk Lead for Trials

Novo Nordisk Pharmaceuticals; Kuala Lumpur; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical company in Kuala Lumpur is seeking a Clinical Quality & Risk Manager to oversee quality assurance and risk management for clinical trials. Responsibilities include conducting risk assessments, implementing mitigation plans, and ensuring compliance with regulations. Candidates should have at least 5 years of experience and a relevant bachelor's degree. This role is pivotal in promoting data integrity and participant safety within clinical development activities.

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 in compliance with ICH-GCP.
• Broad understanding of clinical R&D and global regulations.

Responsibilities

• Oversee quality assurance and risk management activities for clinical trials.
• Identify potential risks and implement mitigation strategies.
• Drive strategic quality planning to align clinical quality goals.

Skills

Quality Assurance

Risk Management

Clinical Development

Data Analysis

Education

Bachelor’s degree in Life Sciences

Master’s degree in related field

Job description

A leading pharmaceutical company in Kuala Lumpur is seeking a Clinical Quality & Risk Manager to oversee quality assurance and risk management for clinical trials. Responsibilities include conducting risk assessments, implementing mitigation plans, and ensuring compliance with regulations. Candidates should have at least 5 years of experience and a relevant bachelor's degree. This role is pivotal in promoting data integrity and participant safety within clinical development activities.