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. The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
2. Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
3. The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
4. Identify gaps and areas for improvement and propose CAPA.
5. Supports start-up and provides local expertise.
6. SSU experience is considered a plus
CRA activities
7. Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets
8. Provides protocol and related study training to assigned sites.
9. Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs
10. Conducts co-monitoring visits, if required
11. Completes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOP
12. Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
13. Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
14. Ensure inspection readiness of the study and sites
15. Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
16. Attends disease indication project specific training and general CRA training as required
17. Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
18. Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
19. Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.
Education Required:
20. BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.
21. Experience in oncology global trials preferred
Other Qualifications:
22. Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
23. At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
24. Experience in oncology/hematology trials preferred
25. Excellent communication and interpersonal skills
26. Excellent organizational skills and ability to prioritize and multi-task
27. Fluent in English & German (writing and speaking)
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Travel: up to 60%
Salary Range EU: 55,100.00 EUR - 68,900.00 EUR
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.
28. Fosters Teamwork
29. Provides and Solicits Honest and Actionable Feedback
30. Self-Awareness
31. Acts Inclusively
32. Demonstrates Initiative
33. Entrepreneurial Mindset
34. Continuous Learning
35. Embraces Change
36. Results-Oriented
37. Analytical Thinking/Data Analysis
38. Financial Excellence
39. Communicates with Clarity