Sso Clinical Project Manager(Cpm)

3 settimane fa

Milano, Italia Novartis A tempo pieno

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 Start-up Manager in the development of country/cluster/hub study execution plans and timeline commitments
- Participates in the recruitment sub-team 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 cross-border 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

**Division

  • Sso Contracting Specialist

    1 mese fa

    Milano, Italia Novartis A tempo pieno

    100,000+ That’s how many 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...

  • Clinical Project Manager

    6 ore fa

    Milano, Italia PSI CRO A tempo pieno

    **Company Description** PSI is an award-winning full-service CRO, bringing together more than 2,700 dynamic and knowledgeable individuals working to help impact the future of medicine in more than 60 countries around the world. We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new...

  • Clinical Project Manager

    4 settimane fa

    Milano, Italia JSB SOLUTIONS S.R.L A tempo pieno

    **JSB Solutions,** azienda di consulenza nata nel 2009 con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un **Clinical Project Manager**: - (JSB.SRF.23.014)_ da inserire nel nostro team di consulenti in area **Clinica.** La risorsa avrà la possibilità di indicare una preferenza tra la nostra sede di Sesto Fiorentino (Firenze) o di...

  • Stage Project Manager

    1 settimana fa

    Milano, Italia CPM Italy A tempo pieno

    **Vuoi un mini spoiler su CPM?** Ci prendiamo cura dei maggiori brand mondiali da oltre 80 anni attraverso diverse attività, dal merchandising alle vendite, dalla consumer activation al supporto clienti fino alla formazione sul prodotto. Questa è CPM, una realtà internazionale forte e dinamica, come le persone che ne fanno parte. Per te, rappresenta la...

  • Stage Project Manager

    23 ore fa

    Milano, Italia CPM Italy A tempo pieno

    Vuoi un mini spoiler su CPM? Ci prendiamo cura dei maggiori brand mondiali da oltre 80 anni attraverso diverse attività, dal merchandising alle vendite, dalla consumer activation al supporto clienti fino alla formazione sul prodotto. Questa è CPM, una realtà internazionale forte e dinamica, come le persone che ne fanno parte. Per te, rappresenta la grande...

  • Project Manager

    4 settimane fa

    Milano, Italia Worldwide Clinical Trials A tempo pieno

    **Requisition Number** **6146** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...

  • Clinical Project Manager Phase I

    1 mese fa

    Milano, Italia JSB SOLUTIONS S.R.L A tempo pieno

    **JSB Solutions**, azienda di consulenza nata nel 2009 con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un **Clinical Project Manager Phase I**: - (JSB.SRF.23.004)_ da inserire nel nostro team di consulenti in area **CRO** per la nostra sede di **Milano**. **Clinical Project Management per trials clinici di fase I di almeno 3 anni**. La...

  • Junior Translational/clinical Project Manager

    1 mese fa

    Milano, Italia IFOM A tempo pieno

    2023/07 | Milan IFOM is an internationally recognized non-profit cancer research institute supported by the Italian Association for Cancer Research (AIRC) based in Milan within a highly dynamic urban environment. IFOM continuous success is ensured by the recruitment of highly selected undergraduate, graduate and post-graduate researchers from over 24...

  • Global Clinical Contract Manager Milan

    4 settimane fa

    Milano, Italia Resourcing Life Science A tempo pieno

    **Company Description** Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Global Clinical Contract Manager office based in Milan. Job Overview - Management of the...

  • Clinical Project Manager Phase Iii

    1 mese fa

    Milano, Italia JSB SOLUTIONS S.R.L A tempo pieno

    JSB Solutions, società di servizi nel settore Life Science che offre consulenza, gestione di studi clinici e sviluppo software, con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un **Clinical Project Manager **(_JSB.FRK.24.011_) da inserire all'interno della nostra divisione Clinica per la nostra sede di **Milano**. - management dei trials...

  • Clinical Study Manager

    1 settimana fa

    Milano, Italia Quanta Part Of Qcs Staffing A tempo pieno

    Clinical Study Manager - Pharmaceuticals - Various EU Locations We have an exciting opportunity with a North Carolina based client who's focus on the research, development, and commercialisation of products helps patients who haven't yet received necessary care.You would contribute to their portfolio of life changing products as a Clinical Study...

  • Manager, Site Management Franchise Lead

    3 giorni fa

    Milano, Italia Worldwide Clinical Trials A tempo pieno

    **Requisition Number** **6163** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...

  • Clinical Supply Chain Manager.

    3 settimane fa

    Milano, Italia Psi A tempo pieno

    Job DescriptionIn this role, you will undertake activities to assess, plan and set up trial supply schemes for assigned projects and manage vendors involved in clinical supplies and interactive response technology.Office-based or Home-basedYou will:Analyze clinical trial protocols and translate requirements to establish an efficient supply chain solution for...

  • Associate Clinical Project Management Director

    1 mese fa

    Milano, Italia Novasyte A tempo pieno

    Join us in our exciting journey!! IQVIA is expanding in EMEA!! We currently have a Associate Clinical Project Manager Director to work sponsor-dedicated to one of our pharmaceutical clients Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The...

  • Clinical Research Manager

    4 settimane fa

    Milano, Italia Mil Fortrea Clinical Development Ltd Filiale Italiana A tempo pieno

    Clinical Research Manager - Home Based Italy page is loaded Clinical Research Manager - Home Based Italy Apply locations Milan Italy time type Full time posted on Posted 4 Days Ago job requisition id 2417063 As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea...

  • SP - Project Manager

    1 mese fa

    Milano, Provincia di Milano, Italia Project S.r.l. A tempo pieno

    Siamo alla ricerca di una figura di Project Manager con un livello di seniority middle/senior (almeno 5 anni di esperienza) e una buona conoscenza della lingua inglese sia a livello scritto che parlato. Competenze richieste: Le attività si svolgeranno sia in smart working che on site presso la sede di Milano

  • Sp - Project Manager

    1 mese fa

    Milano, Italia Project S.R.L. A tempo pieno

    Siamo alla ricerca di una figura di Project Manager con un livello di seniority middle/senior (almeno 5 anni di esperienza) e una buona conoscenza della lingua inglese sia a livello scritto che parlato. Competenze richieste: Le attività si svolgeranno sia in smart working che on site presso la sede di Milano

  • SP - Project Manager

    1 mese fa

    Milano, Italia Project S.r.l. A tempo pieno

    Siamo alla ricerca di una figura di Project Manager con un livello di seniority middle/senior (almeno 5 anni di esperienza) e una buona conoscenza della lingua inglese sia a livello scritto che parlato.Competenze richieste: Le attività si svolgeranno sia in smart working che on site presso la sede di Milano

  • SP - Project Manager

    1 settimana fa

    Milano, Italia Project S.r.l. A tempo pieno

    Siamo alla ricerca di una figura di Project Manager con un livello di seniority middle/senior (almeno 5 anni di esperienza) e una buona conoscenza della lingua inglese sia a livello scritto che parlato.Le attività si svolgeranno sia in smart working che on site presso la sede di Milano

  • SP - Project Manager

    1 settimana fa

    Milano, Lombardia, Italia Project S.r.l. A tempo pieno

    Siamo alla ricerca di una figura di Project Manager con un livello di seniority middle/senior (almeno 5 anni di esperienza) e una buona conoscenza della lingua inglese sia a livello scritto che parlato.Le attività si svolgeranno sia in smart working che on site presso la sede di Milano