Clinical Operations Associate

hace 5 días

Lleida, Lérida, España BeiGene A tiempo completo
About the Role

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.
Requirements
  • 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 clinical trial management and regulatory requirements.
  • 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.
About BeiGene

BeiGene is a global biotechnology company dedicated to developing innovative cancer therapies that improve patient outcomes and quality of life. We are committed to fostering a collaborative and inclusive work environment that values diversity, equity, and inclusion.

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