Key Responsibilities

• 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

Role requirements :

• 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
• 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.
•  Self-motivated, structured and committed way of working.
• Ability to prioritize and high coordination skills
• Demonstrated collaboration and communication skills.

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 people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: http://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. http://www.novartis.com/careers/benefits-rewards

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.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message

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:
http://talentnetwork.novartis.com/network