Clinical Studies Scientist II

JOB SUMMARY

Coordinate clinical studies execution in clinical sites world-wide . Provide support to principal investigators and their team: on-site trainings, monitoring of sites and clinical data, manage study-related administration and logistics tasks. Ensure that studies and data management are performed in compliance with GCP, Ethical and Regulatory frame.

Key Accountabilities

• Develop clinical study design.
• Write clinical study protocols.
• Write study monitoring plan.
• Train study team on the relevant part of clinical studies.
• Ensure statistical plan is properly performed and followed.
• Ensure data management plan is properly performed and followed.
• Ensure study risk analysis plans is properly performed.
• Ensure that CRFs (case report forms) are well designed, completed and collected.
• Prepare documentation to submi...