What Youll Do: Regulatory Submission Management Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS. Handle regulatory submissions for medical devices, GMOs, and local country requirements in countries where CTIS is not
What Youll Do Support Clinical Project Manager / Director in completing clinical project management activities; support activities throughout all phases of a clinical project, including any SOP-required deliverable as appropriate Update Clinical Project Manager / Director
What Youll Do: Oversee and guide eTMF processes and specific timelines assessments for each trial; monitor against trial progress and ensure trial activity is in compliance with relevant processes; suggest and implement alternative solutions for issues