Jun 10, 2024


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 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.

About the Role

Your responsibilities include, but are not limited to:

• Supports and collaborates with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio in country SSU strategy and global study team to ensure SSU timelines and deliverables are met according to country commitment

• Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable and also ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms

• Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders as well as reportable events and notifications to IRB/IEC and Health Authorities as applicable

• Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness and ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

• Implements innovative and efficient processes which are in line with Novartis strategy and supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.

• Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned and in satellite countries oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary

• Ensures sites are prepared for “Green Light” and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site “Green Light” and oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations

• Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required and leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead

Required Experience & Qualifications:

• 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 German

• Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials

• 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

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

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You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. 

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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Rotkreuz (Office-Based)
Research & Development
Full time
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Study Start-Up Manager

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