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Job Location | Hyderabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Medical / Healthcare |
Functional Area | General / Other Software |
EmploymentType | Full-time |
5! The number of projects you will be leading to develop our growing pipeline of Gene Therapy products. We are looking for an experienced professional in the area of drug product development for Gene Therapy-based drug products, with special focus on viral vectors. As a member of Pharmaceutical Development in the Cell and Gene Therapy Development Unit, Technical Development NBEs, you will play a key role in the development of parenteral dosage forms of viral and non-viral vectors, for gene therapy, for preclinical and clinical studies, as well as in the development of market formulations. Your key responsibilities:Your responsibilities include, but not limited to: Basic 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. Perform comprehensive DB Set up Plan and execute full go live of DB set up. Overall, will ensure quality DB set up within Medidata RAVE EDC system. Perform impact analysis for proposed modifications to existing domains, permitted choices for discussion with Governance as necessary. Support development and testing of all new Medical & Clinical Solutions team Library objects needed for clinical studies. 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. Contribute to the review of global SOPs. Ensure alignment between OC Global Library Objects and Metadata Repository. Understanding and Leading the Life Science Data Hub (LSH) programming activities for all new Medical & Clinical Solutions team projects implemented on Novartis Clinical Data Standards platform. 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. Review Data Transfer Specifications (DTS), grant access to vendor/CRO for loading data into IWC.EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse team s representative of the patients and communities we serve.Minimum requirements What you ll bring to the role: University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree. Basic knowledge/understanding and experience of applications like Oracle Clinical and standard reporting systems like CDISC/SDTM. 7 + years experience in drug development, with at least 5 years in Data Management activities. Experience in managing outsourced studies or working for a CRO is desirable. Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding. Good organizational and project management skills. Good negotiation skills. Ability to mentor, coach within Data Management and cross functionally. Ability to work independently, under pressure, demonstrating initiative and flexibility. Good interpersonal and communication skills and ability to operate effectively in an international environment.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 whats 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!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,
Keyskills :
researchaccountingclient managementconsultingmarket researchgene therapymedidata raveclinical datadata standardsdata managementdata extractionoracle clinical