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Senior Clinical Data Analyst

6.00 to 8.00 Years   Pune   13 Jan, 2021
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaStatistics / Analytics

Job Description

The Senior Clinical Data Analyst (SCDA) shall be responsible for data processing activities on a project and shall ensure quality standards according to SOPs and ICH-GCP. Areas of responsibility shall include; data cleaning and query generation, support in data entry and CRF tracking, medical coding, SAE reconciliation and quality support on projects The CDA shall support on project meetings and telephone conferences where required. The SCDA shall act as a Project Lead on a projects where required.Key Accountabilities Review the respective study protocol/CRF Perform data cleaning (manually or automatically) and generate DCFs. Perform medical coding Perform SAE reconciliation Development of project-specific status reports Support data entry for UAT and production Track and review CRFs Setup and review of study documents and ensure proper documentation on projects DM QC as assigned Review of study databases including data-entry screens Input in development of SOPs, improvement initiatives and processes Mentoring of staffSkills Ability to work with cross-functional groups Ability to understand complex organizational relationships Willingness to work overtime Detail-oriented with ability to work creatively and flexible in a fast-paced environment Good English knowledge Good knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG) Basic knowledge of PC or Unix SAS Demonstrate a sound awareness of all relevant regulations, including GCPQualificationsEducation Bachelor s degree (or equivalent) in a life science field, medical qualification (e.g. Nursing) or relevant Data Management experienceLanguage Skills Good English knowledgeMinimum Work Experience At least 6 years experience in a Data Management role in a clinical research environment. Experience in using any EDC system or SAS is preferred.,

Keyskills :
deliverybasisbillingcrfdata managementdata entrydata analysisclinical datadata cleaningmedical codingdata processingclinical researchquality standardssae reconciliationmedical terminology

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