Sso Clinical Trial Associate

2 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 (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 Clinical Trial Associate in the Study & Site Operations (SSO) team in Italy #GCO
Job Purpose:
The SSO CTA reports into the Study Start Up (SSU) Team Lead and supports SSO Study Start-Up Manager and SSO Clinical Project Manager in assigned studies during set-up and whole study lifecycle in compliance with Novartis processes, GCP/ICH and regulatory requirements.

Your responsibilities include, but are not limited to:

- Supports country SSU strategy in close collaboration with SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments
- Provides logistic support to SSU CRA, CRA, CPM, SSU Manager in all phases of the clinical trial
- Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
- Supports vendor selection, set-up and maintenance
- Investigator Folder (IF) and Trial Master File (TMF) management
- Checks site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
- Implements innovative and efficient processes which are in line with Novartis strategy Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
- 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._

**Minimum requirements**

Experience/professional Requirements
- 1+ years' of experience in clinical operations
- Preferably with understanding of clinical drug development with particular emphasis on trial set-up and clinical drug management
- Profound knowledge of MS Excel, MS Word, MS PowerPoint, ideally knowledge in SAP
- 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

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Italy

**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

  • Sso Clinical Trial Associate

    5 giorni fa

    Milano, Lombardia, 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 between...

  • Clinical Trial Ambassador

    5 giorni fa

    Milano, Lombardia, Italia Syneos Health Clinical A tempo pieno

    OverviewThe Clinical Trial Ambassador will establish, cultivate, and maintain scientific relationships with investigators and study coordinators to support enrollment while developing a strong understanding of clinical practice as it relates to areas of interest. This position interacts with various internal and external stakeholders, with a focus on...

  • Clinical Trial Ambassador

    2 mesi fa

    Milano, Italia Syneos Health Clinical A tempo pieno

    **Description** **You are a listener, an educator and a gifted cultivator of new and exciting opportunities grounded in science.** The Clinical Trial Ambassador (CTL) will establish, cultivate, and maintain scientific relationships with investigators and study coordinators to support enrollment while developing a strong understanding of clinical practice...

  • Sso Contracting Specialist

    7 giorni 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 Trial Ambassador

    2 mesi fa

    Milano, Italia Syneos Health Clinical A tempo pieno

    **Overview** The Clinical Trial Ambassador will establish, cultivate, and maintain scientific relationships with investigators and study coordinators to support enrollment while developing a strong understanding of clinical practice as it relates to areas of interest. This position interacts with various internal and external stakeholders, with a focus on...

  • Sso Country Head Portfolio

    2 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 -...

  • Sso Contracting Specialist

    2 mesi fa

    Milano, Italia Novartis A tempo pieno

    387143BR **SSO Contracting Specialist**: Italy **About the role** The SSO Contracting Specialist reports into the Study Start Up (SSU) Team Lead and is accountable for coordination, preparation, and execution of clinical study contracts in close collaboration with SSO Study Start-Up Managers, SSO Clinical Project Managers and SSO Finance Specialists in...

  • 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 -...

  • Clinical Trial Coordinator/clinical Trial

    2 mesi fa

    Milano, Italia Labcorp A tempo pieno

    **Labcorp Drug Development** is looking to hire a **Clinical Trial Coordinator** in Italy. In this position, you will be fully dedicated to a **single sponsor** and you will have a **full-time** **and **permanent** **contract**. As a Labcorp Drug Development employee dedicated to an FSP project, you will bring your specialized discipline to a core team...

  • Clinical Trial Associate, Sponsor Dedicated

    7 giorni fa

    Milano, Italia Novasyte A tempo pieno

    Internal Job Description - Clinical Trial Administrator, Single Sponsor dedicatedJob Overview: - CTA performs daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. By assisting in the coordination and administration of the study...

  • Clinical Research Associate

    1 mese fa

    Milano, Italia Ab Lavoro A tempo pieno

    Descrizione azienda Siamo una società di consulenza, specializzata nella ricerca e selezione del personale, autorizzata dal Ministero ad operare come Agenzia per il Lavoro (Aut. Min. Lav. n. 13/I/5640), su tutto il territorio nazionale. Che tu voglia inserirti nel mondo del lavoro, o sia alla ricerca di nuovi stimoli professionali, AB Lavoro è pronta a...

  • Clinical Research Associate

    3 settimane fa

    Milano, Italia Ab Lavoro A tempo pieno

    Descrizione azienda Siamo una società di consulenza, specializzata nella ricerca e selezione del personale, autorizzata dal Ministero ad operare come Agenzia per il Lavoro (Aut. Min. Lav. n. 13/I/5640), su tutto il territorio nazionale. Che tu voglia inserirti nel mondo del lavoro, o sia alla ricerca di nuovi stimoli professionali, AB Lavoro è pronta a...

  • Junior Clinical Trial Manager

    3 settimane fa

    Milano, Italia BI Italia Spa A tempo pieno

    **THE POSITION**: The Junior Clinical Trial Manager (JCTM) is a key position in local on the delivery of Boehringer Ingelheim’s pipeline and accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at local level. **For this position we offer a one year fixed term contract with external...

  • Clinical Trial Manager

    3 settimane fa

    Milano, Lombardia, Italia IQVIA A tempo pieno

    Clinical Trial ManagerGlobal or Regional Applicability: RegionalTrial Management services provide local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to-end project management from start-up...

  • Clinical Trial Manager

    3 settimane fa

    Milano, Lombardia, Italia IQVIA A tempo pieno

    Clinical Trial ManagerGlobal or Regional Applicability: RegionalTrial Management services provide local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to-end project management from start-up...

  • Junior Clinical Trial Manager

    5 giorni fa

    Milano, Lombardia, Italia BI Italia Spa A tempo pieno

    THE POSITION:The Junior Clinical Trial Manager (JCTM) is a key position in local on the delivery of Boehringer Ingelheim's pipeline and accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at local level.**For this position we offer a one year fixed term contract with external agency...

  • Clinical Trial Assistant

    5 giorni fa

    Milano, Lombardia, Italia Novasyte A tempo pieno

    Clinical Trials Assistant - Multisponsor - Milano (Hybrid)Job Overview:Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions: Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU)...

  • Clinical Research Associate

    3 settimane fa

    Milano, Italia Boston Scientific Corporation A tempo pieno

    **Clinical Research Associate**: - Remote Eligible: Remote in Country- Onsite Location(s): Milan, MI, IT**Additional Locations**: Italy-Milan; Italy-Rome **About The Role**: The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world...

  • Clinical Trial Manager

    5 giorni fa

    Milano, Lombardia, Italia 150 Icr Italy - Itl A tempo pieno

    Clinical Trial Manager (local) page is loaded Clinical Trial Manager (local) Apply locations Italy, Milan Italy, Rome time type Full time posted on Posted 5 Days Ago job requisition id JR120825 ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced...

  • Clinical Trial Manager

    2 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 Trial Manager**: - (JSB.SRF.22.093)_ da inserire nel nostro team di consulenti in area **CRO **per la nostra sede di **Milano**. **Clinical Project Management di almeno 3 anni in contesti farmaceutici** e sarà inserito...