Principal Clinical Database Developer

Job Description

261082BRPrincipal Clinical Database DeveloperJob DescriptionYour responsibilities:Your responsibilities include, but not limited to:1. Serves as the primary program/ therapeutic area lead ensuring timely and quality deliverables a. Leads the effective and timely development and implementation of clinical systems b. Uses advanced database programming techniques to solve study specific complex validation or custom development needs c. Understand and manages study metadata to compliment data provisioning in compliance with global standards. d. Coordinates database development and conducts database testing e. Develops data models to support data review and acquisition standards to adapt for study/ project level needs and specificities. 2. Establishes and maintains strong working relationships with study teams, and functional lines 3. Acts as a technical consultant ensuring appropriate development, maintenance, and use of all system capabilities such as electronic data capture, database programming, edit check programming, report programming, electronic data load, interactive response technology, electronic patient reported outcomes, metadata management and other clinical database development activities 4. Ensures that systems meet regulatory requirements, internal standards and are deployed with quality. 5. Lead independently or participate in improvement initiatives and/ or non- clinical projects 6. Communicate and ensure that project objectives and priorities are met according to agreed timelines, strategies, quality and scientific standards. 7. Responsible for Database development activities for multiple studies in parallel across TAs 8. Coordinates resources to ensure project objectives are met 9. Contributes to the development/ updates of Clinical Systems processes and supports training on systems and processes to ensure compliance 10. Recruit, train, mentor, supervise and/ or coach junior staffMinimum requirementsBachelor s degree preferably in computer science, management information systems, or other related area. Fluent English (oral and written) 1. At least 7 years of experience in setup of clinical databases/ Data Warehouse using RAVE or OC- RDC or LSH. 2. Excellent interpersonal and written and oral communication skills, with the ability to effectively communicate cross- functionally 3. Advanced technical skills: a. Expert knowledge of EDC - Medidata RAVE preferred b. Excellent understanding of relational databases c. Microsoft Office Suite d. Knowledge of other programming languages such as SQL, PL/ SQL, VBscript, SAS, C# or Java preferred e. Experience in Custom Functions is an added advantage. 4. Demonstrated ability to consistently produce detailed, high quality deliverables in a team environment 5. Excellent problem- solving, project management negotiation and conflict resolution skills 6. Excellent understanding of Drug Development Process, ICH- GCP and Health Authority Guidelines & Regulations.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 :
mysqlsqledidataravecustomerrelationspatientreportedoutcomesdatabaseadministrationglobaldrugdevelopmentstatementsofworksowelectronicdatacapturesqlserverdatamodelsmanagementinformationsystems