SSO Study Start-Up Manager

Job description

Band Level 4 Job Description Summary: #LI-Hybrid Job Posting Title: SSO Study Start-Up Manager Location: Prague, Czech Republic The SSO Study Start-Up (SSU) Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, Good Clinical Practice/International Council for Harmonization (GCP/ICH) and regulatory requirements in a standalone country, OPC (operating country) or satellite country. 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. Job Description: Key Responsibilities: - Lead and manage country study start-up activities from country allocation through Country& Site Regulatory Green Lights, ensuring timelines, quality, and deliverables are met. - Collaborate with country, cluster, portfolio, and global study teams to align on start-up strategy, commitments, and execution plans. - Prepare, review, and finalize submission packages for EU CTR submission, and other regulatory bodies, including amendments and required study documents, incl. adapting and reviewing Informed Consent Forms....