SSO Study Start-up Manager

Job description

Band Level 4 Job Description Summary: The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in Denmark. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team. Act as primary back-up and deputy of the country manager. Accountabilities: Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio Collaborates with SSO Country / SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages and review of Informed Consent Forms Prepa...