Clinical Studies Scientist II

As a Clinical Study Manager, you will be responsible for developing clinical study designs, writing study protocols, and monitoring plans. You will play a crucial role in training the study team on relevant aspects of clinical studies and ensuring the proper execution of statistical and data management plans. Your key responsibilities will include: - Developing clinical study design - Writing clinical study protocols - Writing study monitoring plan - Training study team on relevant parts of clinical studies - Ensuring statistical plan and data management plan are properly performed - Ensuring study risk analysis plan is properly executed - Designing CRFs (case report forms) and ensuring they are well completed and collected - Preparing documentation for EC/IRB submission and following up during the study - Conducting site initiation visits for training site personnel on protocol, study procedures, and regulatory requirements - Monitoring the study throughout its duration - Performing study close-out activities - Managing clinical databases and data analysis - Preparing final clinical study reports - Ensuring compliance with GCP and ethical/regulatory frameworks - Preparing study documentation for regulatory submissions Your role will also involve internal networking with R&D, Regulatory Affairs, Design Quality, and Operations colleagues. (Note: No additional details about the company were provided in the job description),