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Senior Data System Designer

Bengaluru, KA
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  • Biotechnology & Science
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Job Details

Manages Data Systems to ensure the timely creation, validation, testing, deployment and maintenance of databases required by Pharm-Olam projects. Analyzes study protocol and project requirement(s), identifies data quality rules and design data entry interfaces in accordance with the Protocol, DMP, SOP, client requirements, regulatory guidelines and internal standard.Provides technical support to the project team for the Data Systems employed in processing and management of study data encompassing reporting tools for data review and DM metrics, performance and quality generation.Resolves data integrity issues and addresses database design inconsistencies over time.Manages and monitors interactions with project specific third party vendors.Identifies process optimization to improve efficiencies. Develops and maintains standard library (global, therapeutic and client specific).Provides technical support to Pharm-Olam staff and Project Team for existing databases, including Oracle and EDC based, user interface, reporting tools, metrics generation and CDISC standards.Key Responsibilities (% of Time)(15%) Deploy complete, accurate and efficient database(s) for the purpose of Data Management and Data Processing. To conduct and support design and programming of data entry interface, data structures and quality rules for assigned projects and studies. Support and ensure the preparation, transfer and integration of clinical data from internal and external sources into the study database. Provide data in various formats and applications to data customers . Ensure high quality deliverables, good cooperation with internal and client partners and active participation in project teams. Develop programs for transformation of the acquisition of data from the core Data Systems to a definitive study database to meet Pharm-Olam/client project standards. Ensure in conjunction with Data Project Manager adherence to Pharm-Olam standards and validation of all study related calculations and data mappings. Responsible for data exchange with external parties, for example, the client, third party vendors (Labs, ECG, etc) and Safety/Independent Data Monitoring Committees, as required. Provide ongoing day to day end-user support to the project team(s) to ensure all systems and programs are executing correct and efficiently. Setup and support of data review and reporting tools required by DM stakeholders SAS programmers, Clinical, Medical, Pharmacovigilance and Regulatory Affairs and where required Client Study Management Team. Provide technical expertise and programming support for Pharm-Olam projects and data management staff. Communicate project status and key project issues to DPM and DS Management. Assist in developing new Data Systems programming procedures and processes. Keeps current with technological advances and coordinates activities with Global Training and Information Technology Team in an effort to maximize their potential use in managing data. Provide mentoring and training of other. Assist in delegating work. Run and review department metrics, plus perform some root cause analysis.(15%) Supports, maintains and utilizes standardization of CRF and eCRF modules, data quality rules, data structures, data libraries, code lists, and dictionaries in conjunction with input from other functional areas and project teams and in accordance with CDISC standards.(10%) Provides technical expertise to project teams in the operational aspects of Data Systems and support, ensuring consistency among systems to avoid redundancy, inefficiency, or potential problems; and keeps current with technology trends as they affect data systems management.(10%) Manages and coordinates activities of EDC vendors through the project cycle of all EDC studies from study start up to archival ensuring adherence to Pharm-Olam procedures and policies.(10%) Provides training in use of systems, including but not limited to Oracle/Clinical and EDC, as well as, the application and use of CRF and eCRF modules, data quality rules, data structures, data libraries, code lists, and dictionaries to other functional areas and project teams.(10%) Manages and coordinates external vendors activities ensuring their adherence to contract specifications.(5%) Manages and coordinates the integration / consolidation and archival of databases in accordance with applicable Pharm-Olam, client and/or regulatory guidelines.(5%) Evaluates external vendors and technologies as to their ability to perform in accordance to Pharm-Olam goals, procedures, and quality standards prior to contract finalization.(5%) Identifies areas of process improvement that may be provided by standardization and/or technology to increase efficiency, quality and timeliness of data management processes and deliverables.(5%) Provides metric reports for monitoring the progress of projects and processes for reporting to management and project teams.Working RelationshipsData Systems Specialists, SAS Programers - DailyManages activities to database developmentResponsible for ensure regulatory compliance to deployment systemsResponsible for complete, accurate and efficient systems deploymentData Project Managers - DailyCoordinate activities between functions.Development and delivery of requirements.Reporting of project statusTrainingBiostatistics Leads As NeededDevelopment and delivery of project requirements and reporting of project status.Clinical Experts/Project Teams As NeededProvide specific project requirements.Provide standard training.External Vendors As NeededCoordinate transmission of data files.Ensure compliance of procedures and processes to project specifications.
Degree: MCA/ PGDCA | ME/ M.Tech./ MS (Engg/ Sciences)

Additional Degree: BE/ B.Tech (Engineering) | BCA (Computer Application)

Experience: 5-10


Application Programming | Business/Systems Analysis | ERP/CRM | Quality Assurance/Testing
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