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 submit project to EC/IRB (ethical Committee) and follow up with them during the study.
Conduct site initiati...