Novartis Business Services
SSOStudyStartUpManager
“SSO Study Start-Up Manager at Novartis Business Services. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, clinical operations, project management. Lead and manage country study start-up activities from country allocation through Country& Site Regulatory Green Lights, ensuring timelines, quality, and deliverables are met.. Prepare, review, and finalize submission packages for EU CTR submissio”
What You'll Achieve.
ensuring timelines, quality, and deliverables are met; Ensure compliance with ICH/GCP, SOPs, local regulations, financial standards, and Health Authority/IRB/IEC requirements; ensure TMF inspection readiness
Industry & Context.
problem solve; mediate complex issues
Up to 10% travel is required, Capable of leading in a matrix environment, without direct reports
What They're Looking For.
Must Have
Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials, Fluent in both written and spoken English and Czech, Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring, project management capabilities with demonstrated ability to problem solve and mediate complex issues, Thorough understanding of the international aspects of drug development process, including knowledge of international standards (GCP/ICH), health authorities (FDAA), local/National Health Authorities regulations and Novartis standards
Nice to Have
advanced degree with clinical trial experience and/or project management
What You'll Do.
Lead and manage country study start-up activities from country allocation through Country& Site Regulatory Green Lights
and deliverables are met.
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.
Ensure timely completion of substantial modification submissions
including coordination with Regulatory Affairs
and relevant local stakeholders.
Coordinate responses to RFIs in collaboration with local and global teams.
Maintain inspection-ready Trial Master File documentation by ensuring accuracy
and timely filing of country start-up documents.
Ensure compliance with ICH/GCP
and Health Authority/IRB/IEC requirements.
Lead site selection and support study feasibility activities in collaboration with Feasibility Managers
Site Partnership Managers
Clinical Project Managers
Collaborate with Contract and Finance Specialists on contract and budget set-up and review.
Leads/chairs local SSU team meetings in assigned studies
participates in global study team meetings
Accountable for timelines
and quality of country TMF documents in study start-up to ensure TMF inspection readiness
How You'll Work.
Team & Collaboration
Collaborate with country, cluster, portfolio, and global study teams to align on start-up strategy, commitments, and execution plans.; Collaborate with country, cluster, portfolio, and global study teams to align on start-up strategy, commitments, and execution plans.; Ensure timely completion of substantial modification submissions, including coordination with Regulatory Affairs, CTA Hub, and relevant local stakeholders.; Coordinate responses to RFIs in collaboration with local and global teams.; Lead site selection and support study feasibility activities in collaboration with Feasibility Managers, SSU CRA, Site Partnership Managers, Clinical Project Managers, and study teams.; Collaborate with Contract and Finance Specialists on contract and budget set-up and review.; Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required
Communication Scope
Communicates effectively in a local/global matrixed environment
Process & Methodology
project management, project management capabilities, project planning
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