BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
1. Work with country or global teams to plan and implement Phase IV GMA-sponsored clinical trials, interventional or non-interventional
2. This includes all aspects of study management and oversight, including working with the CRO, engaging with non-GMA stakeholders for alignment, project management, data management, safety planning, etc.
Essential Functions of the job:
3. Create the global governance structure and implementation process for these studies.
4. Build capabilities and infrastructure for GMA-sponsored studies; interventional and non-interventional.
5. Build the templates, tracking and reporting process for these studies for leadership and non GMA members.
6. Create a global Sharepoint site to house all required documents and oversee all data is added to the appropriate systems (GMA portal, ClinOps portal).
7. Work with the responsible party (eg Country Medical Director, HEOR lead) to create the implementation and operations plan for a GMA-sponsored study.
8. Create the governance structure and planning forum for each study.
9. Manage and track study-specific activities and deliverables.
Education Required:
10. Master's or Doctorael level degree required.
Qualifications:
11. Master's or Doctorate level degree with 10 + years of experience in the pharmaceutical industry.
12. 5 + years of experience in managing company-sponsored clinical trials within the pharmaceutical industry.
13. Preferred: Experience conducting post-marketing company-sponsored trials (interventional & non-interventional).
14. Experience managing a CRO, understanding of global regulatory requirements for company-sponsored trials.
15. Detail-oriented, organized, excellent written & verbal communication skills.
16. Able to function in a fast-paced environment, self-directed.
Supervisory Responsibilities:
17. Yes
Computer Skills:
18. Excel, PowerPoint, Project Management Software, Smartsheet, data management databases (eg CTMS), Veeva or similar.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
19. Fosters Teamwork
20. Provides and Solicits Honest and Actionable Feedback
21. Self-Awareness
22. Acts Inclusively
23. Demonstrates Initiative
24. Entrepreneurial Mindset
25. Continuous Learning
26. Embraces Change
27. Results-Oriented
28. Analytical Thinking/Data Analysis
29. Financial Excellence
30. Communicates with Clarity