Study Start-Up Manager

Novartis seeks a dynamic and experienced SSO Study Start-Up Manager (SSUM) to join our dedicated team. This pivotal position reports directly to the Study Start-Up (SSU) Team Lead, and lead the local Study Start-Up teams for designated trials, holding significant responsibilities within our organization, ranging from trial and budget planning to ensuring on-schedule completion of trial start-up activities.

As the SSO Study Start-Up Manager, you play an integral role in ensuring that all trial start-up deadlines and results align with our commitments.

Key responsibilities:

The SSUM is responsible for study planning, SSU processes, and activation of assigned projects, ensuring compliance with Novartis standards, GCP/ICH guidelines, and regulatory requirements.

Your duties will, but not be limited to:

• Steering all SSUs of assigned projects in close cooperation with the SSO Feasibility Manager, SSO Site Partnership Manager, and the global study team.
• Backing the country's SSU strategy, working closely with the SSO Study Start-Up Team Lead, SSO SSU Country Head, and SSO Country Head Portfolio (Early & Late Stage).
• Collaborating with the SSO Country Head Portfolio, SSO Portfolio Team Leads, and the global study team to ensure the SSU schedules and results meet country commitments.
• Responsible for timely startup activities from country allocation to the Green Light stage (ready to initiate site) in assigned projects.
• Facilitating close collaboration with local IRBs/IECs and Health Authorities, where necessary.
• Ensuring efficient startup activities, including overseeing the preparation of initial/amendments submission packages and consent form reviews.
• Coordinating timely responses to deficiency letters working closely with local and global partners.
• Responsible for the timely, accurate, and high-quality country TMF documents, ensuring readiness for inspection, while adhering to financial standards, prevailing legislation, ICH/GCP guidelines, local/National Health Authorities regulations, and Novartis' standards

Essential requirements:

• A degree in a scientific/healthcare discipline with experience in clinical operations or project management.
• Minimum of 5 years' experience in clinical operations in a project management role, and/or in monitoring clinical trials.
• Skilled in leading in a matrix environment, without direct reports.
• Understanding of all aspects of clinical drug development, with a specific emphasis on trial set-up, execution, and monitoring.
• Proven problem-solving skills and ability to handle complex issues.
• Understanding of the international aspects of the drug development process, including solid knowledge of international standards (GCP/ICH), Health Authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis' standards.

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Division

Development

Business Unit

Development

Location

Italy

Site

Milano

Company / Legal Entity

IT08 (FCRS = IT008) Novartis Farma S.p.A.

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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