Study Start-up Manager

6 mesi fa

Milano, Italia Novartis A tempo pieno

390355BR

**Study Start-Up Manager - Study & Site Operations**:
Italy

**About the role**

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 Study Start Up Manager in the Study & Site Operations (SSO) team in Italy #GCO.
The SSO Study Start-Up Manager reports into the Study Start Up (SSU) Country Head and 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.
Your responsibilities include, but are not limited to:

- 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.
- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO SSU Country Head and SSO Country Head Portfolio (Early & Late Stage) and collaborates with SSO Country Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and results are met according to country commitments
- Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects
- Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable
- Ensures that study start-up activities are conducted and completed on time, including oversight on the preparation of initial/amendments submission packages and review of Informed Consent Forms
- Coordinates timely response to deficiency letters in close collaboration with local and global partners
- Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness
- Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

What you will bring to the role:
Education
- A degree in scientific/health discipline with experience in clinical operations and/or project management, is preferable

Experience/professional Requirements
- 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

Key Competencies
- Demonstrated ability to problem solve and mediate complex issues
- Understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards

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

Accessibility and accommodation

**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

Milano

**Company/Legal Entity**

Novartis Farma IT

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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