Clinical Research Lead
4 days ago
Job Summary:
We are seeking a Clinical Research Lead to join our project team. As a key member, you will be responsible for the overall management of clinical trials, ensuring compliance with SOPs, regulations, and ICH guidelines.
About the Role:
- Oversee site qualification visits, feasibility, site selection, and start-up activities.
- Lead the preparation of Human Research Ethics Committee (HREC) submissions with sites.
- Negotiate site budgets and execute site contracts.
Key Responsibilities:
- Monitor clinical trials and ensure adherence to protocol requirements.
- Perform site initiation visits and train Investigators and trial staff on protocol requirements.
- Conduct interim monitoring visits and maintain eTMF filing.
- Maintain study tracking in Clinical Trial Management System (CTMS).
What You'll Bring:
- Excellent leadership and communication skills.
- Ability to work independently and collaboratively as part of a team.
- Strong problem-solving and analytical skills.
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