Regulatory Compliance Manager

2 weeks ago


kwai tsing district, Hong Kong SAR China IQVIA Argentina Full time
About the Role

IQVIA is seeking a Regulatory Compliance Manager - Clinical Trials to join our team in Argentina. As a Regulatory Compliance Manager, you will be responsible for ensuring that our clinical trial operations comply with regulatory requirements and guidelines.

Key Responsibilities
  • Develop and implement regulatory compliance strategies to ensure compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Conduct site audits and monitoring visits to ensure compliance with regulatory requirements.
  • Work with sites to develop and track subject recruitment plans to meet project needs.
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout the clinical trial lifecycle.
  • Stay up-to-date with changing regulatory requirements and guidelines, and ensure that our operations remain compliant.
Requirements
  • Bachelor's degree in a relevant field, such as life sciences or healthcare.
  • At least 3 years of experience in clinical research or regulatory compliance.
  • Excellent knowledge of and skill in applying applicable clinical research regulatory requirements, including GCP and ICH guidelines.
  • Strong written and verbal communication skills, including a good command of the English language.
  • Ability to work effectively in a fast-paced environment and prioritize multiple tasks and projects.


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