VN250 Clinical Trial Associate (Cta)
- Buenos Aires
- Permanente
- Tiempo completo
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
- IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and Novartis requirements; document oversight and tracking
- 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)
- 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
- 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**Desirable Experience & Qualifications**:- Ability to prioritize and high coordination skills
- Demonstrated collaboration and communication skills**#GCO****Why Novartis?**766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!**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****Education**:- Commercial or medical training (e.g., vocational qualification, bachelor’s degree), Medical records administrator or equivalent education, preferably with experience in clinical operationsLanguages:- Fluent in both written and spoken English, local language as neededExperience/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 contractingCompetencies:- 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 standardsSkills & Knowledge:- Strong process and system understanding
- Self-motivated, structured and committed way of working**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.**Division**Global Drug Development**Business Unit**GCO GDD**Country**Argentina**Work Location**Buenos Aires**Company/Legal Entity**Novartis Argentina S.A**Functional Area**Research & Development**Job Type**Full Time**Employment Type**Regular**Shift Work**No**Early Talent**No
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