338398BR
May 17, 2022
India

Job Description

With over 400 active trials, Novartis GDQ is committed to delivering support to make the clinical trial process more efficient and patient-friendly. We are in search of those who are passionate about applying their experience to support and reimagine clinical trial Data Operations.
Position Purpose:
As Global Development Quality (GDQ) representative, support the Global Drug Development (GDD) Data Operations by providing expertise and guidance to ensure that clinical data flow and processes are fit for purpose and meet Novartis standards and Health Authorities expectations. Engage with GDD business and quality teams to advocate quality attitude and ensure clinical data management is fit for purpose and completed with the highest quality.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Provide quality advice and oversight to ensure required standards and regulations are followed during conduct of clinical studies. Partner across GDD functions and Novartis business units/ divisions to support programs to embed digital capabilities, data science and technology into the drug development and the end-to-end clinical trial processes (e.g. Statistical Analysis Plan, Statistical Programming results, e-Clinical, e-PRO, e-SAE, RAVE-EDC, bots, visualization tools, statistical modeling).
• Be an ambassador for the Novartis values and behaviors and support the journey towards an inspired, curious, unbossed and self-aware organization. Ensure relevant quality documents (guidelines, SOPs, Quality Standards, etc.) are in place to cover new processes and technologies.
• Support GDD and GDQ teams to ensure new technologies are risk-assessed and understood. Provide consultancy on Data Operations, Data Analytics and Statistical Programming due diligence activities, before and during integration of an acquired or in-licensed asset as needed. Support Health Authorities inspections and internal audits in assigned areas/ activities/ projects.
• Proactively identify regulatory, quality and compliance risks for assigned areas/ activities/ projects and establish mechanisms to mitigate these risks. Ensure Clinical Trial Quality Risk Management (CT-QRM) concepts are applied in GDD Data Analytics and Statistical Programming processes.
• Provide expertise and guidance to business partners in investigations, root cause analysis and risk mitigation assessments of quality incidents and change management process.
• Lead cross-functional projects to continuously improve Novartis quality standards, processes and systems to ensure better process adherence and to simplify the way we work. Provide comments to relevant regulations during consultation period as requested.
• Develop and deliver training to ensure adherence to standards. Foster a culture of collaboration and capability building by delivering educational and learning preparations (e.g. training, lessons learned and successes sharing, regular meetings with internal and external partners/ stakeholders).


Diversity & Inclusion / EEO

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

Minimum Requirements

WHAT YOU’LL BRING TO THE ROLE:

• Bachelor degree in statistics, computer science, mathematics, life sciences or related field with 5+years of work experience in a programming role supporting clinical trials/ or in pharmaceutical industry. Master degree or equivalent is a plus.

• Experience in the use of SAS or R within a Statistical Programming environment to develop and validate deliverables. Good experience in contributing to statistical analysis plans and/or constructing technical programming specifications. Data science analytics experience a plus.

• Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).

• Good communications and negotiation skills, ability to work well with others globally

• Proven ability to produce timely and quality deliverables under guidance.


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.

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


WHY NOVARTIS?
769 million lives were touched by Novartis medicines in 2020, 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!
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Global Drug Development
QA GDD
India
Hyderabad, AP
Quality
Full Time
Regular
No
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338398BR

Associate Director Data Operations-GDQ

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