SpeedStartUp For Clinical Studies

Study Start Up Specialist

Being accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures
Being responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.
Coordinating and liaising with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.