9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.
Your responsibilities include, but not limited to:
• Performs site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial.
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate.
• Performs continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.
• Collaborates with Clinical Study Manager and Medical Science Liaison to ensure recruitment plans and execute contingency plans, as needed.
• Play a role in the global development of innovative drugs (antibody drug, tumor immunotherapy, regenerative medicine, etc.).
What you’ll bring to the role:
• Manage investigational sites and conduct appropriate clinical trials.
• Ensure and supports overall ICH-GCP/J-GCP conformity and compliance in clinical study.
• Delivering innovative drugs to patients as quickly as possible.