REQ-10013982
ก.ค. 17, 2024
France
Summary
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
About the Role
Major accountabilities:
- 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) and 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
What you will bring to the role :
- Commercial or medical training (e.g., vocational qualification, bachelor’s degree), Medical records administrator or equivalent education, preferably with experience in clinical operations
- 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:
- Strong process and system understanding
- Ability to prioritize and high coordination skills
- Demonstrated collaboration and communication skills
You’ll receive:
- An attractive salary
- An annual bonus
- A focus on your career development
- Access to our Quality of Life at work program
- Flexible working
- Advanced social coverage for you and your loved ones
- 27 days of paid leave & 14 days of RTT per year
- Various employee recognition programs
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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Development
Innovative Medicines
France
Paris Headquarter (Novartis Pharma S.A.S.)
FR12 (FCRS = FR012) Novartis Pharma S.A.S.
Research & Development
Full time
Regular
No