About the role

Aplyr's Quick Take

This role is about managing the start-up phase of clinical trials in Italy, ensuring that all necessary activities and documentation are completed on time and in compliance with regulations. It involves leading a team and coordinating with various stakeholders to activate study sites efficiently.

Good fit

Ideal candidates have experience in clinical operations, particularly in study start-up or trial monitoring. They should be comfortable working in a collaborative, matrixed environment and have a solid understanding of regulatory processes.

Worth noting

The role emphasizes compliance and quality, which might appeal to those who thrive in structured environments. However, the spec is vague on day-to-day responsibilities, which could lead to uncertainty in the role's expectations.

Job Description Summary

The Study Start-Up Manager (SSUM) reports to the Study Start-Up Team Lead and Study Start-Up Country Head and is accountable for end‑to‑end study planning, study start‑up activities, and site activation deliverables for assigned projects in Italy.

The role ensures that study start‑up activities are delivered on time, with quality and compliance, in line with Novartis processes, ICH/GCP, and applicable regulatory requirements, from country allocation through to Green Light (Ready to Initiate Site).

Job Description

Global Clinical Operations (GCO) is the powerhouse behind Novartis clinical trials, redesigned to accelerate study start-up, enhance trial delivery, and ensure patients gain timely access to potentially life‑changing treatments. Every day, we act as the vital link between science and medicine. Imagine the impact you could have as a Study Start-Up Manager in the Study & Site Operations (SSO) team in Italy.

Key Responsibilities:

Lead all Study Start-Up (SSU) activities for assigned studies, in close collaboration with internal study team and global study teams.
Contribute to the country SSU strategy, working closely with the SSU Team Lead, SSU Country Head, and Country Portfolio team
Partner with global and country stakeholders to ensure SSU timelines, milestones, and deliverables are met according to country commitments.
Be accountable for timely site activation, from country allocation through Green Light / Ready to Initiate Site milestones.
Oversee and ensure completion of study start‑up activities.
Coordinate timely and effective responses to ethics committee and Health Authority deficiency letters, working closely with local and global partners.
Ensure timelines, accuracy, and quality of country documentation, maintaining inspection readiness throughout the start‑up phase.
Ensure full compliance with Novartis SOPs, financial standards, prevailing legislation, ICH/GCP, and regulatory requirements.

Essential requirements:

Previous experience in clinical operations, preferably in a role involving study start-up activities, project oversight and/or clinical trial monitoring
Proven ability to lead in a matrix environment
Understanding of the clinical drug development process, with focus on: Study start‑up.
Experience working with Ethics Committees/IRBs, Health Authorities, and country‑level regulatory processes

Desirable requirements:

Strong problem‑solving skills, with the ability to navigate and resolve complex operational and regulatory issues
Excellent collaboration and stakeholder‑management skills in cross‑functional and global environments
Strong understanding of international clinical research standards (ICH/GCP)
Knowledge of Health Authorities (e.g. EMA/FDA) and local/national regulatory requirements
High attention to quality, timelines, and inspection readiness mindset

Education:

Degree in a scientific or healthcare discipline
Experience in clinical operations and/or project management is strongly preferred

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.