Clinical Database Programmer

2 days ago


Mumbai, India V5 Global Services Full time

**Clinical Database programmer****:
Industry Pharma / Biotech / Clinical Research

Location Haryana Gurgaon

Experience Range 3 - 5 Years

Qualification B.TECH, BCA

Job Description
- About Us
- About Company
- Roles and Responsibility
- FUNCTION: Clinical Database Programmer - Gurgaon location- REPORTING TO: Global Clinical Data Strategy & Systems- LOCATION: Gurgaon-
Review functional requirement specification documents created by project study teamsDevelop, program, validate and maintain eCRF’s and additional modulesCreate and maintain library of standard CDASH compliant CRFsEnsure that appropriate edit check specifications and quality control checks are implemented as per clinical investigation protocolCompletes mid study database updates as specified per Change Request documents and proceduresEnsure accuracy and validation of clinical database developmentProvide annotated and blank CRF to businessAssist in updating processes to any change in regulationResponsible for SOP preparation and updatePerform User and Site Administration to include site set up and assignment of roles, permissions, and eLearning requirementsPartner with CoE Data Management team members to prioritize deliverablesProcess and reviews database accounts regularly to ensure integrity of database access and securityLiaise with EDC product support team for trouble shooting any issue identified during study build or executionMaintain all required Configuration Specifications and Quality Control documents as requiredMaintaining database design documentation adudit-readyPROFILE REQUIREDBE/BTech, ME/MTech, MS in Biotechnology / Bioinformatics / Pharmacy/ Computer Science or related domainMinimum industrial experience of about 3 years in data management for clinical trialExpertise in database designing and programming rules. Minimum 1-2 years experience in Data Management. Min 1 year experience in Database design.Knowledge of Oncology, Cardiology, Hematology, Neurology therapeutic area is desirable.Min 1yr Database design experience on Zelta platform (previously Merative Clinical Development and formerly IBM Clinical Development) with ‘Basic Designer’ certificate.Certificate on additional modules like Endpoint Adjudication, Data Migrator, Smart Report is highly desirable.EDC expertise is highly preferrableGood understanding of data visualization tool such as PowerBIExperience with CDASH and SDTM standardsExperience in Medical devices is an advantageTeam player, able to work in an international environmentFluent in EnglishAbility to motivate in a dynamic environmentFlexibility to work according to different time zones as/if required



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