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270233BRSenior Clinical ProgrammerJob DescriptionYour responsibilities:Your responsibilities include, but are not limited to:1. Lead LSH/ Data loading activities for assigned/ Project level activities for phase I to IV clinical studies in Novartis Global Drug Development. 2. Lead in the review of Data Transfer specification documents and provide comments if required. Perform Data Loading activities so that data flow is available once the third party data is obtained from external vendors. Address QC findings prior to Production Loads. 3. Responsible for Data Loading for all models ( both inbound/ outbound for both Legacy/ future models). 4. Responsible for Study Conduct activities that includes Conformance of Clinical data to internal Novartis data formats and continuous flow of data to downstream systems. Perform Masking/ Blinding activities as per the Data management Plans and perform testing before providing to the stakeholdersMinimum requirementsBA/ BS/ MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Fluent English ( oral and written). 1. Excellent experience and proven skills in the use of Mapping/ ETL or Data Warehousing experience.2. Good understanding of Metadata Standards Management like CDISC SDTM, LSH. 3. Good knowledge of Global Clinical Trial Practices, procedures and Data presentation. 4. Good understanding of related applications that are Data collection tools ( like OC, Rave) and ancillary data. 5. Good understanding of Regulatory requirements. 6. Excellent communications and negotiation skills, ability to work well with others globally. 7. Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs 8. Good understanding of regulatory requirements relevant to Statistical Programming ( e.g. GCP, ICH) and clinical study practices, procedures and methodologies. 9. Good communications and negotiation skills, ability to work well with others globally.Why consider Novartis750 million. That s how many lives our products touch. 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 livesWe 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. We are Novartis. Join us and help us reimagine medicine.DivisionGlobal Drug Development Business UnitGDO GDD CountryIndia Work LocationHyderabad, AP Company/ Legal EntityNov Hltcr Shared Services IndFunctional AreaResearch & Development Job TypeFull TimeEmployment TypeRegular,
Keyskills :
lifesciencesdatamanagementdatastructuressharedservicesdatacollectioncomputersciencedatawarehousinglobaldrugdevelopmentphaseidataflowdataloadingclinicaldatacontinuousflowdrugdevelopm