Clinical Operations Associate
hace 1 semana
We are seeking a highly motivated and detail-oriented Clinical Operations Associate to join our team at BeiGene. As a key member of our Clinical Operations department, you will play a critical role in supporting the study team with clinical operations tasks and ensuring compliance with regulatory requirements.
Key Responsibilities- Support Clinical Operations Tasks: Assist the study team with clinical operations tasks, including development of clinical trial documents, preparation of internal and external meetings, and maintenance of clinical operations tracking tools.
- Ensure Compliance: Ensure compliance with ICH/GCP, local regulations, SOPs, and regulatory requirements, including the development and review of Clinical Operations Work Instructions and SOPs.
- Support Trial Master File (TMF) Activities: Support the setup, maintenance, and close-out of the TMF, including document collection, uploading, and quality checks.
- Mentor Junior Associates: Mentor junior associates and provide guidance and support as needed.
- Education: Bachelor's degree (or equivalent) in a scientific, medical, or healthcare discipline.
- Experience: Minimum 1 year of experience in clinical operations, with a strong understanding of ICH/GCP, local regulations, and SOPs.
- Skills: Excellent interpersonal skills, strong organizational skills, and effective written and verbal communication skills. Proficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.
- Opportunity to Work with a Global Biotech Leader: BeiGene is a global biotech leader with a strong commitment to innovation and excellence.
- Collaborative and Dynamic Work Environment: Our team is collaborative, dynamic, and passionate about making a difference in the lives of patients.
- Professional Development Opportunities: We offer opportunities for professional growth and development, including training and mentorship programs.
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