We are recruiting for a GSS Specialist II to be office based in Lucerne, Switzerland. This is a fantastic role to join a growing, dynamic team.
Role and responsibilities:-
Country submissions & local language materials:
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Development of local language materials including local language Informed Consents and translations.
- Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols and to establish reasonable approval timelines
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Oversight and tracking of clinical research-related payments and payment reconciliation at study close-out.
- Oversight, Denied Parties Screening and maintenance of financial systems.
- Financial forecasting and tracking of operational budget in conjunction with Clinical Research Director.
Management & quality oversight:
- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments and to maintain quality and compliance in assigned protocols in the country.
- Works in close collaboration internally with GCTO country operations (CRM, CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations, HQ and Regional functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Provides support and oversight to local vendors as applicable.
Local process oversight:
- Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- Enters and updates country information in clinical, regulatory, safety and finance systems.