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edc programmer - rave inform oc in Bengaluru

posted:
location
bengaluru, karnataka
function
Information Technology
position type
permanent
reference number
920732
contact
randstad india
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job description

?? Design specifications of EDC Trial Build services for core configuration, eCRFs, data validations (DVS) and reporting
? Develop configuration of the EDC trial by utilizing the trial design specifications for eCRFs, DVS, custom functions integrations and reporting
? Collaborate with the project team to ensure the configuration is completed on time with high quality
? Perform project management activities for all phases of the project lifecycle, may include managing multiple timelines and deliverables for (single or multiple clients) and managing client communications as assigned as the technical lead
? Provide Quality Control on deliverables developed by other team members
? Maintain all required Configuration Specifications and Quality Control documents as required by SOP and Processes
? Collaborate with training team as an EDC Subject Matter Expert and perform training
? Work on consulting efforts related to EDC systems including UAT, global library/standards development
? Ensure compliance with industry quality standards, regulations, guidelines and procedures
? Other duties as assigned


Benefits
?Exposure to advanced technologies into clinical research

Client Introduction
?Client seamlessly orchestrates clinical technology and expertise to help accelerate the clinical development process. We provide a spectrum of customized data management services and solutions including EDC, Data Management, Clinical Reporting, Data Standardization and an innovative Clinical Data Repository platform with advanced visualization and analytical capabilities. Through experience and innovation we allow life science organizations to manage and proactively make decisions regarding clinical trials and programs.

skills

?rave or inform

qualification

?? Minimum 5-13 years in Pharmaceutical/Biotechnology industry or equivalent
? Experience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages
? Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards (CDASH, SDTM) preferred
? Excellent verbal and written communication skills
? Detail oriented, ability to multitask with strong prioritization, planning and organization skills
? Excellent team player
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