Clinical Database Developer

4^4 - The number of projects that you would lead or support across multiple therapeutic areas.
We are looking for an experienced professional with robust programming competencies (SAS, SQL, Python, R, etc.) & strong communication skills for our Clinical Database Development Reporting & Analytics function. As a member of this function, you would be primarily responsible for seamless end to end data flow of Clinical & Operational Data from Data Collection, Transformation , Reporting & Analytics & provisioning of data to downstream applications & teams.

Your responsibilities include, but are not limited to:

• Develop the eCRF layout and corresponding database according to documented trial specific requirements using components from existing libraries
• Create, test and maintain trial specific plausibility and consistency checks
• Provide data transfer specifications for third party data
• Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes
• Develop database specifications and provide support for outsourced trials .Create, file and maintain appropriate trial documentation
• Program and test procedures of various levels of complexity, from documented trial specific requirements, within the clinical database management system using relevant SQL, PL/SQL, C#, VB script,SAS. Maintain and update procedures as required for protocol amendments or required post production changes
• Creation & execution of trial design reports based on trial metadata
• Understanding of Novartis Clinical Data Standards for procedures development

University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics, or equivalent degree Fluent English (Oral and Written) At least 2-3 years of experience in clinical database programming, setup of clinical databases and CRF design, and procedure /validation programming, as part of the setup of clinical databases, gained in the pharmaceutical industry, CRO or Life science related industry as well as the following:

• Strong knowledge of SQL, PL/SQL, C#, VB script, SAS. OC/RDC or INFORM experience preferred
• Understanding of clinical data management systems and/or relational databases as applied to clinical trials
• Attention to detail, quality, time management and customer focus. Strong verbal and written communication skills to work with our global partners and customers.
• Ability to translate technical concepts for non-technical users in the areas of clinical database design and procedure development
• Understanding of Drug Development Process, ICH-GCP and Health Authority guidelines and regulations.

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Global Drug Development

GDO GDD

India

Hyderabad, AP

Nov Hltcr Shared Services Ind

Research & Development

Full Time

Regular

No