Clinical Research

• Responsible at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports
• Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study

Clinical Trial Manager, Oncology Experience Required

Regional Clinical Study Manager

Senior Biostatistician – FSP

Clinical Trial Manager – FSP

Biostatistician II – Client Dedicated

Senior Biostatistician