- London, England, United Kingdom +1 more
- Hybrid
- Full-time · Manager
Drive country-level performance and compliance across assigned clinical trial protocols, taking ownership of clinical study start-up, budget formulation, contract negotiation, and regulatory approvals.
Locations (2)
- London, England, United Kingdom
- Rahway, New Jersey, United States
Responsibilities
- Lead the development, negotiation, and execution of Clinical Trial Research Agreements (CTRAs) and site budgets within fair market value.
- Oversee trial financial tracking, payment reconciliations, milestone tracking, and financial compliance (including FCPA and anti-corruption requirements).
- Direct country-level regulatory authority and IRB/IEC submissions and approvals for assigned protocols.
- Ensure all local language materials, patient-facing documents, and informed consents are accurately translated and compliant with ICH/GCP and local laws.
- Partner closely with Clinical Research Associates (CRAs), Clinical Trial Coordinators (CTCs), Finance, and Legal to remove bottlenecks and achieve milestone readiness for trial sites.