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. Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards, within timelines and budget
2. Builds solid knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study Manager
3. Supports the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study Manager
Essential Functions of the job:
Regional Trial Support & Collaboration
4. Develops regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants.
5. Acquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelines
6. Supports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, ..)
7. Establishes good collaboration with Regional Clinical Study Manager, the Global Study Management Associate and other key stakeholders regionally and globally
8. As required, supports CRAs with various activities such as monitoring visit preparations, TMF filing,
Timelines, Planning and Execution
9. Creates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists
10. Sets up the countries and sites in the region in the appropriate systems e.g. eTMF, CTMS, ..and makes sure information is kept up to date
11. Supports system access requests for the region/country and ensure these are managed appropriately across the study life cycle, supports user account management for users in region
12. Might support the local adaptation of global documents under supervision of the Regional Clinical Study Manager
13. May assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager (e.g., Informed consent forms, regional Pharmacy Manual, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and other relevant regional study plans and charters)
14. Supports study start up in region/country in close collaboration with the regional study start up team and the Regional Clinical Study Manager
15. Supports the organization of study specific investigator meetings together with the Regional Clinical Study Manager and the Global Study Management Associate
16. Supports the TMF specialist with country/site level TMF creation and maintains the country/site level TMF including regular review and QC of TMF documents as per the study TMF QC plan
17. Helps resolving any regional/country specific issues related to clinical supplies in collaboration with relevant stakeholders
18. Supports the data cleaning activities and contributes to the follow up of outstanding information for region/country
19. Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team
20. Might assist in resolution of routine study questions from clinical trial sites
21. Might support the maintenance of information for region/country in relevant public registries (e.g CT.gov)
22. Supports the Regional Clinical Study Manager with providing all relevant information from region/country to be included in the Clinical Study Report
Quality
23. Supports the identification of operational risks and works with the Regional Clinical Study Manager to recommend solutions for discussion with appropriate team leadership
24. Learns and shares best practices in clinical operations methodologies, systems and processes with the emphasis on quality and compliance
25. Might support the preparation of sites for quality assurance audits and inspections
26. Suggests improvements to enhance the efficiency and the quality of the work performed on assigned projects
27. Might support the development of local/regional tools, working instructions and SOPs
Budget
28. Supports set up of vendors for activities outsourced in region/country
29. Supports management of regional study budget incl PO set up
30. Supports PO set up for regional vendors
Supervisory Responsibilities: N/A
Competencies:
31. Embracing Change
32. Communicating Effectively
33. Working in Teams
34. Learning
Education Required: Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred
*exceptions might be made for candidates with relevant clinical operations experience
Computer Skills: MS Office
Other Qualifications:
35. Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes
36. 1 or more years of experience in clinical research within biotech, pharma or CRO industry
Travel: Limited travel might be required
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.
37. Fosters Teamwork
38. Provides and Solicits Honest and Actionable Feedback
39. Self-Awareness
40. Acts Inclusively
41. Demonstrates Initiative
42. Entrepreneurial Mindset
43. Continuous Learning
44. Embraces Change
45. Results-Oriented
46. Analytical Thinking/Data Analysis
47. Financial Excellence
48. Communicates with Clarity