SSO Study Start-Up Manager

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.
• 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.
• Maintain inspection-ready Trial Master File documentation by ensuring accuracy, completeness, and timely filing of country start-up documents.
• Ensure compliance with ICH/GCP, SOPs, local regulations, financial standards, and Health Authority/IRB/IEC requirements.
• 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
• Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness

Essential Requirements

• A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable. Fluent in both written and spoken English and Czech
• Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
• Up to 10% travel is required
• Capable of leading in a matrix environment, without direct reports
• Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
• Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
• Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards

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Desirable Requirements

• Strong interpersonal, negotiation and conflict resolution skills; Communicates effectively in a local/global matrixed environment