Associate Director Clinical Trials

7 days ago


Sydney, New South Wales, Australia Recruitment Pty Full time

Job Description

We are seeking an experienced Associate Director Clinical Trials to join our team at On Q Recruitment. The successful candidate will be responsible for leading the study start-up department and ensuring timely and compliant trial initiation.

About the Role:

You will oversee the development and implementation of effective processes and procedures to maintain regulatory compliance and optimize trial start-up efficiency. This includes managing the preparation, submission, and review of ethics and regulatory documents for new clinical trials.

Your Key Responsibilities:

  • Lead the study start-up department and manage the preparation, submission, and review of ethics and regulatory documents.
  • Develop and implement SOPs and best practices for study start-up.
  • Ensure adherence to regulatory requirements and ICH-GCP guidelines.
  • Collaborate with cross-functional teams, including principal investigators, sponsors, and regulatory agencies.
  • Track ethics submission progress and provide regular updates to stakeholders.

Requirements:

  • 3-5 years of experience in clinical research, preferably in regulatory submission or study start-up coordination.
  • Strong leadership and organizational skills.
  • In-depth knowledge of GCP, ICH guidelines, and local regulatory requirements.
  • A tertiary qualification in life sciences, health sciences, or a related field.


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