Job Description Summary
Internal Role Title: SSO Study Start-Up Manager
Location: Sydney, Australia #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the Role:
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. In satellite countries acts as primary back-up and deputy of the country manager.
Job Description
Key Responsibilities:
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Support country SSU strategy in collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio, and SSO Cluster Head Portfolio
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Ensure timely start-up activities from country allocation until Green Light (ready to initiate site milestone) in assigned projects
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Collaborate with local IRBs/IECs and Health Authorities to ensure study start-up activities are conducted and completed on time
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Prepare and finalize local submission packages for IRB/IEC, CTA Hub, and Health Authorities, including subsequent amendments
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Coordinate timely responses to deficiency letters in collaboration with local and global stakeholders
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Oversee local SSU team activities in assigned studies to achieve start-up timelines and quality execution
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Lead the development of country site initiation and patient enrolment plans together with SSU CRA, CPM, and SSU Lead
Essential Requirements:
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A degree in a scientific or health discipline is required; an advanced degree with clinical trial experience and/or project management is preferable.
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Minimum 5 years’ experience in clinical operations in a role that oversees project management and/or monitoring clinical trials.
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Capable of leading in a matrix environment without direct reports.
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Thorough understanding of the international aspects of the drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), and local/National Health Authorities regulations.
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Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues.
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Strong interpersonal, negotiation, and conflict resolution skills.
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Fluent in both written and spoken English; local language proficiency as needed.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model
