Main Responsibilities:
Clinical Trial Set up
1. Ensure timely delivery of clinical trial supplies for assigned projects based on input from CMC and CTT
2. Attend study kick off meetings and elaborate the overall supply plan
3. Develop the most suitable packaging solution
4. Consider supply risk management in study planning
5. Coordinate activities for completion of primary and secondary packaging
6. Develop compliant label text and print booklets / labels
7. Generate a material list taking into consideration the pack types and blinded status of the study
8. Participate in the IRT setup, complete CTS specific documentation, set up should take into consideration study specific requirements, clinical trial supply expiry
Clinical Trial Distribution
9. Develop a distribution plan with the external service utilising the best most efficient distribution network in terms of timelines, quality and cost
10. Select the most appropriate carrier option for the clinical trial supplies
11. Ensure all relevant distribution documentation is completed in advance including transport conditions and available to the CMO
12. Complete and review Import licenses, proforma invoices where appropriate
13. Provide the study team CROs responsible for importation, quantities required for specific countries
Clinical Trial returns / destruction and close out
14. Complete returns process with the external service provider
15. Provide complete details to study team
16. Complete destruction at the earliest available time
17. Receive Certificates of destruction
Documentation
18. Set up binder / TMF and eTMF for each clinical study
19. Maintain binder throughout duration of study
20. Close binder and provide to relevant clinical team for long term storage
Communication
21. Ensure excellent communication between all stakeholders
22. Present the overall clinical supply program to the CMC team
23. Communicate and escalate any challenges or potential supply issues to team leader of CPCTS and where appropriate CMC/CTT
Commercial packaging
24. Part of Commercial image definition team, with representatives from CMC, life cycle, DRA, QA TRA and marketing.
25. Work to define the primary and secondary packaging requirement for the commercialisation of the product
26. Single point of contact of packaging suppliers, contract packagers, and packaging test laboratories
27. Assess packaging technical changes and impact on overall product quality
28. Create a registration packaging plan that includes all relevant activities and is in collaboration with CMC Team
Artwork
29. Provide mock ups to DRA for submission
30. Provide the technical approval of the final artwork.
31. Provide fully approved artworks to the CMO for printing
Serialisation
32. Application manager responsibility
Qualifications and Experience:
33. Relevant working/residency permit or Swiss/EU-Citizenship required
34. University degree or equivalent working experience in life sciences
35. At least 3 or more years’ experience in the field of Commercial packaging or Clinical Trial Supply
36. Knowledge of the relevant international GMP, GDP, GCP regulations
37. Excellent English required