Sso Clinical Project Manager(Cpm) - Milano, Italia - Novartis

Novartis

Azienda verificata

Milano, Italia

1 settimana fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

100,000+ That's how many patients participate in our clinical trials at any given time.

GCO 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 a CPM #GCO

This is a completely new and exciting strategic opportunity where enterprise, agility, autonomy, quality, and superior project management of clinical trial execution are at its core The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies and countries.

The CPM is a Core member of the Global Clinical Trial team (CTT) as Country and Hub representative, responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies in all assigned countries.

If you are interested in bringing value for our patients, being a part of our family environment, then you should apply.

Your key responsibilities:

Supports SSO Study Startup Manager in the development of country/cluster/hub study execution plans and timeline commitments
Participates in the recruitment subteam and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
When requested by the SSO Feasibility Manager supports the study feasibility by providing input to the study protocol, and operational aspects of the study
Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites and Country/Cluster/Hub personnel
Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Conducts or coordinates local investigator meetings as needed and ensures relevant documentation of training is archived in the Trial Master File
Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study conduct
Tracks study budget with appropriate study budget responsible in Country. Ensures timely TCF preparation and submission.

Commitment to Diversity & Inclusion:

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

Minimum requirements

What you'll bring to the role:

Timely submission and delivery of high-quality clinical trial documentation/data
Performance against study commitments at the country/cluster/hub level, including delivery of studies per defined timelines (including study close out), number of patients and quality
Delivery of study milestones in adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements

Desirable requirements:

Minimum 5 years' experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA) and local/National Health Authorities regulations.
Able to lead a crossborder team in a matrix organization
Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
Communicates effectively in a local/global matrixed environment
Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
Fluent in both written and spoken English

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.

That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility.

And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.

Because the greatest risk in life, is the risk of never trying Imagine what you could achieve here at Novartis
Accessibility and accommodation

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