Clinical Trial Associate

il y a 1 semaine

RueilMalmaison, France Novartis Temps plein

390807BR

**Clinical Trial Associate (H/F)**:
France

**About the role**

Location: Rueil-Malmaison, Paris #LI-Hybride
The Clinical Trial Associate (CTA) 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 will be but are not limited to:

- Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
- Sets-up systems
- Supports vendor selection, TPRM process, SIM entries
- IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and Novartis requirements; document oversight and tracking
- Supports Vendor set-up as applicable
- 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)
- Supports preparation and translation of ICF into local languages (including vendor management if necessary)
- Supports preparation of patient facing material
- Responsible for completeness of uploaded trial related documents into CREDI/SUBWAY, including archiving of paper TMFs
- 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

**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._

**Role Requirements**

Essential Requirements:

- Commercial or medical training (e.g., vocational qualification, bachelor’s degree), Medical records administrator or equivalent education, preferably with experience in clinical operations
- Fluent in both written and spoken English, local language as needed
- Ideally several years of working experience with 1+ years' of experience in clinical operations
- Understanding of clinical drug development with particular emphasis on trial set-up, and contracting

Desirable Requirements:

- 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/EMA), local/National Health Authorities regulations and Novartis standards

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our

Novartis is able to offer relocation for this role.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

Rueil-Malmaison

**Company/Legal Entity**

Novartis Pharma France SAS

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes

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