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Job Location | Mumbai City |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Web / Mobile Technologies,Statistics / Analytics |
EmploymentType | Full-time |
Use efficient programming techniques to produce/QC deriveddatasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supportingdocuments and submission documentation. Ensure quality control (QC) is performed on all process andtechnical activities related to derived dataset, table, data listing, andfigure programming in accordance with corporate quality standards,SOPs/Guidelines, ICH-GCP, and/or other international regulatoryrequirements.Qualifications Excellent analytical skills. Proficiency in SAS. Extensive knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and internationalregulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, andproblem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Good business awareness/business development skills (including financial awareness).,
Keyskills :
compliancecfrquality controlgcpwork effectivelycontrolbusiness21 cfrproject managementquality managementmetricstime managementsdtmadamfigurescustomer focusprogrammingquality standardsichgcp