BeOne 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. Accountable forregional study delivery with appropriate inspection readiness quality, within agreed timelines and budget
2. Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study
3. Ensures alignment of regional deliverables with overall study goals
Essential Functions of the job:
Regional Leadership
4. Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study
5. Leads external vendors involved in study delivery on a regional level
6. Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required
7. Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings
8. Leads regional operations meetings with all regional study team members
Timelines, Planning and Execution
9. Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
10. Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these
11. Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders
12. Provides regional input on global study plans as required
13. Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs
14. Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs
15. Ensures regional and country information in study systems and tools is entered and up to date
16. Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports
17. Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC plan
18. Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region
19. Manages the trial data collection process for the region, drives data entry and query resolution
20. As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing
Quality:
21. Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads
22. Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations
23. Ensures inspection readiness for study in region at any point in time throughout the study life cycle
24. Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented
25. Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate
26. Collaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared
27. Leads improvements and partners with CST members to enhance efficiency and the quality of the work performed on assigned studies
28. Contributes to development, optimization and review of work instructions and SOPs as required
Budget and Resources
29. Works with the sourcing team to select and manage regional study vendors
30. Managesregional study budgets
31. Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities
32. Identifies and manages regional team resource needs and establishes contingency plans for key resources
33. Monitors regional resource utilization over study life cycle and liaises with functional managers as needed
Supervisory Responsibilities:
34. Provides performance feedback on team members as required
35. Might mentors junior team members
Computer Skills:
MS Office, Project Planning Applications
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
Other Qualifications:
36. 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
37. Proven experience in clinical research including relevant experience as team lead in clinical functions
38. Experience as CRA is preferred
Travel:
Travel might be required as per business need
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
39. Fosters Teamwork
40. Provides and Solicits Honest and Actionable Feedback
41. Self-Awareness
42. Acts Inclusively
43. Demonstrates Initiative
44. Entrepreneurial Mindset
45. Continuous Learning
46. Embraces Change
47. Results-Oriented
48. Analytical Thinking/Data Analysis
49. Financial Excellence
50. Communicates with Clarity