Sso Clinical Trial Associate

7 mesi 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

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