395079BR
Apr 02, 2024
India

About the Role

Position Title: Study Start-Up Clinical Research Associate

About the role: Study Start-Up Clinical Research Associate

Location – Mumbai #LI Hybrid

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine – imagine the impact you could have as [Role]! #GCO.

Job Purpose:

Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager

Key Responsibilities:

• Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments. Accountable for timely start-up activities from country allocation until site greenlight at assigned sites. Conducts site selection visits, verifies site eligibility for a specific study

• Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation. Ensures that milestones (KPIs) and time schedule for study start-up are met as planned. Facilitates the preparation and collection of site and country level documents

• Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelines. Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.

• Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities. Prepare and finalize site specific documents for submission. Negotiates investigator payments as needed.

• Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed. Updates all systems until site Green Light on an ongoing basis. Supports preparation of audits and inspections as applicable

• Supports reduction of formal site-specific IRB/IEC deficiencies. Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to
ensure TMF inspection readiness. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.

• Implements innovative and efficient processes which are in line with Novartis strategy. Ensures sites are prepared for “Green Light” and is accountable to send the Green Light to SSU. Manager for review and approval.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

Education: A degree in scientific or health discipline, preferably with clinical operations experience.

Experience/Professional Requirement:

• Minimum 3 years’ experience in clinical operations in a
monitoring / site management role

• Advanced understanding of all aspects of clinical drug
development with particular emphasis on trial set-up,
execution, and monitoring

• Central/in-house monitoring or field monitoring experience is desirable

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: https://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.
https://www.novartis.com/careers/benefits-rewards

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: https://talentnetwork.novartis.com/network.

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Development
GCO GDD
India
Mumbai
Research & Development
Full Time
Regular
No
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395079BR

Study Start Up CRA

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