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. Responsible for start-up activities in Germany and Austria and provides local expertise.
2. Identify gaps and areas for improvement and propose CAPA.
3. The Start-up specialist is responsible for collaborating closely with the Regional Clinical Study Manager/Start-up Lead to ensure study timelines are adhered to and required quality standards are maintained.
4. CRA experience is considered a plus
SSUS activities
5. Provide country-specific study start-up expertise, assist on start-up activities, provide support in budget and contract negotiations
6. Follow and/or support (if needed) AMG or GCP-V requirements as requested by German/Austrian laws
7. Retrieves essential documents from study site and performs essential document site file reconciliation. Perform independent quality review of submission packages, submit package to EC (and HA) or support CTIS Submission
8. Review and translate drug labels, ICF, site specific recruitment materials and other applicable documents.
9. Manages sites and site performance by tracking regulatory submissions and relevant milestones
10. Ensure inspection readiness of start-up study and site documentation.
11. Collaborates with Regional Clinical Study Manager/ Start-up Lead and clinical study sites to ensure timely delivery of start-up milestones.
12. Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
13. Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities.
14. Constantly strive for operating excellence, question status-quo and promote innovation.
15. Initiate, support or lead process improvement initiatives
Senior SSUS responsibilities
16. Mentor and manage junior SSU staff
17. Acts as the escalation point person for SSUS(s) with site related issues and concerns
18. May serve as subject matter expert for clinical operations, country regulations and SSU-related activities.
Qualifications:
19. BS or equivalent in a relevant scientific discipline
20. Experienceinoncologyglobaltrials preferred
21. UnderstandsclinicaltrialprocesseswithathoroughknowledgeofICHandassociatedregulatory guidelines
22. 2-5yearsofStart-upexperienceinthepharmaceuticalorCRO industry
23. Excellentcommunicationandinterpersonalskills
24. Excellentorganizationalskillsandabilitytoprioritizeandmulti-task
25. FluentinGerman is a must
26. English (writingandspeaking)
27. EfficientinMicrosoftWord,Excel,MSProject,MSPowerPointand Outlook
Travel:upto 15%
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