Clinical Trial Associate

4 days ago


Montréal, Canada Novartis Full time

100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have #GCO
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 include, 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
- Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
- Provides logistic support to SSU CRA, CRA, CPM, SSU Manager in all phases of the clinical trial
- Implements innovative and efficient processes which are in line with Novartis strategy

**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**

Required Experience & Qualifications:
**Education**:

- Commercial or medical training (e.g., vocational

qualification, bachelor’s degree), Medical records
administrator or equivalent education, preferably with
experience in clinical operations
Languages:

- Fluent in both written and spoken English, local language

as needed
Experience/Professional requirement:

- 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
Competencies: - 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
Skills & Knowledge:

- Strong process and system understanding
- Self-motivated, structured and committed way of working
- Ability to prioritize and high coordination skills
- Demonstrated collaboration and communication skill

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Canada

**Work Location**

Montreal

**Company/Legal Entity**

Novartis Pharma Canada

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No



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