Contract duration: until ..6 (possible extension)
Location: Basel (on-site)
Travel: Up to %
Responsibilities:
1. Serves as a core member of the Global Clinical Trial Team and secure that the region US/CA, EU, LatAm and/or AsiaPac (to which they cover) perspective is considered in relevant aspects of the global set-up and management of the trial(s).
2. Contributes to the review of key regional documents (e.g. FDA/IRB, CTA/EC or other regulatory submission packages, country/site ICF, and others) to support expeditious operational site set-up.
3. Reviews EC/IRB submission responses and facilitate quick feedback.
4. Works with the Regional/Country CRO team and acts as their primary point of contact.
5. Key partner to the trial sites, particularly with the Clinical Research Coordinator staff (e.g. study coordinators/nurses, pharmacists, contracts managers, nutritionists, etc)
6. Supports in set-up and monitoring of Regional/Country site milestones and metrics including Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs)
7. Upon request from gCTM, can coordinate a team of rCTMs in review of Regional/Country site milestones and metrics
8. Actively monitors protocol deviations of Regional/Country sites and addresses/escalates potential risks and issues.
9. Upon request from gCTM and in alignment with study Medical Lead, can coordinate a team of rCTMs in monitoring and assessment of protocol deviations to address/escalate potential risks and issues
10. Collaborates and drives team to develop and implement contingencies for risk mitigation.
11. Identifies opportunities to accelerate trial start-up activities within the region and collaborates with the team on developing actions around these opportunities.
12. Participates in Site Selection Visits and leads assessment, securing input from other relevant functions as needed.
13. Participates in Site Initiation Visits and monitoring visits (as needed).
14. Performs monitoring oversight visits with CRO monitors to ensure study personnel are appropriate
15. Participates in site audits when required and aids in CAPA implementation
16. Works with sites and QA to ensure clinical trial sites are inspection ready
17. Participates in protocol development and master/local ICF process (reviewer)
Experience:
18. Bachelor’s degree with years of pharmaceutical/Biotech clinical development experience.
19. The ideal candidate has very broad experience in Regional level clinical trial management
20. Must have significant experience managing regional/country aspects of activities in Phase I-IV trials, oversight of CROs and vendors.
21. Advantageous to have rare disease trial experience.
22. Proven ability to effectively collaborate with a large group of interdisciplinary teams and Vendors
23. Strong proficiency in GCP/ICH and regulatory issues is essential
24. Up to % travel may be required