Associate Director Clinical Trials
7 days ago
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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