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Clinical Operations Associate
hace 2 meses
We are seeking a highly motivated and detail-oriented Clinical Operations Associate to join our team at BeiGene, Ltd. The successful candidate will support the study team with clinical operations tasks, ensuring compliance and quality checks of the trial master file (TMF).
Key Responsibilities- Support Clinical Operation Managers (COMs) with the setup, maintenance, and close-out of TMF.
- Coordinate document collection from others as appropriate.
- Upload documents to eTMF or other applicable document repositories, ensuring quality documents are uploaded.
- Support TMF completeness activities.
- Follow TMF Plans, applicable SOPs, ICH/GCP guidelines, and regulatory requirements.
- Support actions ensuring the TMF is submission/inspection ready.
- Develop successful cross-functional relationships with internal and external TMF stakeholders.
- Oversee documentation flow within projected timelines and determine the course of action needed to prevent and remediate delays and errors with TMF compilation.
- Support COMs in monitoring and reporting on progress of the TMF to stakeholders.
- Apply lessons learned and demonstrate continuous improvement of documentation management practices across study teams.
- Perform other TMF-related tasks as needed.
- Bachelor's degree (or equivalent) or higher in a scientific, medical, or healthcare discipline.
- Minimum of 1 year of experience in clinical operations (Associate).
- Excellent interpersonal skills, strong organizational skills, and effective written and verbal communication skills across all levels within an organization.
- Ability to work independently and effectively handle multiple priorities in a fast-paced environment.
- Computer skills in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence, through our twelve global competencies, we help get more affordable medicines to more patients around the world.
