Monitoring Services Oversight Manager

Location: Milan, Italy
Full-time, Hybrid, #LI-Hybrid
Through trying, learning, and then trying again, we deepen our understanding of how disease affects life, not just health. We create a restored sense of control and possibility for patients and the people around them. More than 100,000 patients participate in our clinical trials at any given time. GCO (Global Clinical Operations) is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments.
Every day, we are the link between science and medicine – imagine the impact you could have as Monitoring Services Oversight Manager in the Global Clinical Operations team in Italy! #GCO.
Job Purpose:
Primary contact for External Service Providers (FSP) and other Monitoring Services (vendors) to assure adequate quality of the services & performance in Novartis sponsored clinical trials.
Accountabilities:
• Oversees vendor monitoring performance targets per defined quality performance indicators, including site recruitment commitments, timely data entry and issue resolution KPIs.
• Aligns with FSP and other vendor’s managers on CRA and other vendor resource related allocation to trials and studies.
• Requires strong communication skills and ability to influence internal and external stakeholders in order to maximize quality and efficiency of external service providers.
Activities & Interfaces:
·Establishes a process for managing performance (recognition/corrective action) to ensure delivery to the established Key Performance Indicators (KPI)/ Key Quality Indicators (KQI)
·Ensures that the studies under responsibility are conducted as per current legislations, ICH/GCP and Novartis standards
·Pro- active manage FSP and other vendor related collaborations to meet all required expectations
Leadership Capabilities:
Enjoys partnering and collaboration with FSP vendor naturally. Able to keep oversight and distance and is capable to deep dive if needed.
Key Performance Indicators:
1. FSP performance against trial commitments at the country level, including delivery of trials per defined timelines, number of patients and quality
2. Delivery of high-quality clinical data ensuring adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements

What you will bring to the role:
Education:
• A degree in scientific or health discipline required and advanced degree preferable (or, for United States: 4-year degree plus relevant, related healthcare experience)
Languages:
• Fluent in both written and spoken English
Experience/Professional requirement:
• Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials
• Experience and evidence of team leadership capabilities
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
Competencies:
• Decision making capability
• Excellent management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
Skills & Knowledge:
• Demonstrated negotiation and conflict resolution skills
• Fast change adaptability to best partner & influencing with FSP vendor on fast changing landscape
• Trust and rapport building is a very important skill needed
• Good communication skills, ability to influence others & Relationship management
• Excellent communicator and presenter (oral and written)
• Good analytical thinking
• Ability to anticipate potential issues and take appropriate actions with or without supervision
• Digital & tech capabilities
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
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.