摘要
Location: Montréal, #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
We are seeking an innovative, experienced, and agile Clinical Trial Associate (CTA) who is driven by accelerating the start-up of globally run clinical trials and who is motivated in making a difference in reimagining medicine.
About the role:
The 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.
This role will work directly with the SSO Study Start-Up Manager and SSO Clinical Project Manager team and reports to the SSO Start-Up Team Lead.
About the Role
Key responsibilities :
- Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
- Sets-up systems
- 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 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
What you’ll bring to the role:
Essential:
- 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
- Understanding of clinical drug development with particular emphasis on trial set-up, and contracting
- Profound knowledge of MS Excel, MS Word, MS PowerPoint
- 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
Desirable:
- Ideally several years of working experience with 1+ years´ of experience in clinical operations
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Innovative Medicines
CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.
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