Principal Analyst Database Operations - RAVE
Location: Hyderabad, India #LI-Hybrid
About the Role:
Our Global Business Solutions - Biometrics team is looking for Principal Analyst Database Operations experience professionals with RAVE programming and Custom Function skills expertise.
Your key responsibilities:
• Advance knowledge in OC, LSH, SDTM and also carries good understanding of data standards who can lead/assist the development, maintenance and implementation of standards.
• Work with the Governance/approval Board and other DB operations associates and/or members of vendor metadata team to discuss technical issues with implementation of approved OC data structures.
• Document, support development, review and maintain global library copy groups of DCMs, DCIs, Procedures, Views, maintain Form Layout Templates, Extract Macros and Key Templates DCI books for reuse of standard pages for individual trials.
• Within Medidata RAVE EDC system, perform comprehensive DB Set up Plan and execute full go live of DB set up. This includes review of DB set up specifications, development of eCRFs, Technical review of eCRFs and various specifications, technical review of edit checks specifications Programming of edit checks and custom functions if any. In addition, performing technical testing of these activities. Overall will ensure quality DB set up within Medidata RAVE EDC system.
• For studies in scope initiate data extraction, pre-conformance, conformance and post-conformance of clinical data into NCDS standards based on study conformance plan and ensure data refresh as per the schedule. Within Medidata RAVE EDC system, perform comprehensive DB.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What You’ll bring to the role:
• RAVE, Advance knowledge/understanding and experience of applications like Oracle Clinical and standard reporting systems like CDISC/SDTM.
• Ideally 8 or more years’ experience in drug development, with at least 6 years in Data Management activities. Experience in outsourced studies or working for a CRO is desirable.
• Basic knowledge/understanding and experience of applications like Oracle Clinical and standard reporting systems like CDISC/SDTM.
• Good organizational and project management skills. Good technical and problem-solving skills. Ability to work independently, demonstrating initiative and flexibility.
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s li
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 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.
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 [email protected] 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 learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network