Director of Clinical Operations and Quality

2 days ago


Kuala Lumpur, Kuala Lumpur, Malaysia Novo Nordisk AS Full time

We are looking for a director of clinical operations and quality to join our team at Novo Nordisk A/S.

Clinical Operations Manager Operational Excellence

About the Role:

This role involves managing clinical trials and ensuring compliance with international guidelines.

You will be part of the Clinical, Medical and Regulatory (CMR) Department, which is dedicated to driving the success of our clinical trials.

Key Responsibilities:

  1. Feasibility: Develop a feasibility plan that supports site selection decisions.
  2. Study Start-Up (SSU): Oversee the SSU process to ensure timely study start-up.
  3. Quality and Training: Implement quality and training initiatives to ensure audit and inspection readiness.

Requirements:

  • Bachelor's degree or higher qualification in Pharmacy, Life Sciences, or another related field.
  • Minimum 7+ years of experience in clinical operations with 4-5 years of experience in people management.
  • Experience in GCP audits and inspections is highly preferred.
  • Knowledge of clinical trial processes and protocols.


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