Study Startup Lead

Take your career to the next level and be involved in study startup processes in China. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time. 

Office-Based: Shanghai

You will:

• Leads all study startup activities/processes with local project teams.
• In the absence of stand-alone feasibility function, leads activities in feasibility research and site identification process.
• Oversees electronic Trial Master File (eTMF) maintenance during startup phase.
• Leads activities on negotiation of site agreement and/or budget to ensure alignment to the site activation plan.
• Reviews study-specific translations.
• Identifies project-specific issues and escalates to all functions concerned as outlined in the Project Communication Plan.
• Supervises preparation and/or submission of the study dossiers to sites, to the competent authorities, IRBs/IECs, etc.
• Reviews IP-REDs packages.
• Oversees and reports on the site activation progress of the clinical sites.
• If qualified, conducts site selection visits and/or functions as a field trainer for SSVs.