SSO Study Start-Up Manager

About this role

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

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
• Benefits & Rewards:
• Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year; (1 week above the Labour Law requirement); 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Benefit Plus Cafeteria in the amount of 17,500 CZK per year; Meal vouchers in amount of 105 CZK for each working day (full tax covered by company); MultiSport Card, Company Car, Employee Share Purchase Plan. Find out more about Novartis Business Services:
• https://www.novartis.cz
• Commitment to Diversity and Inclusion / EEO paragraph:
• Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.