Job Description

This inclusive employer is a member of myGwork - the largest global platform for the LGBTQ+ business community. Summary The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data. Validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. Further responsibilities shall include providing technical expertise and/or operational leadership regarding all DM operational activities (data cleaning matrices), processes and Data Management documents regarding data validation. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements. SCDA acts as a subject matter expert on DM Systems/processes, providing technical support and expert advice to internal and external sponsors. The SCDA may act as a back-up to or fulfill the Data Management Lead role where required. Skills Good understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc. Experience in clinical research industry. Advanced knowledge of medical terminology and coding dictionaries Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out. Advanced knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation. Basic knowledge of SAS (programmed listings). Basic knowledge of Data standards (CDISC). Good understanding of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work. Proven experience of leading virtual/global Data Management operational team/s to perform DB setup, data cleaning activities. Skills Start-up: eCRF creation/ review, DVS (Edit check creation/review), DMP creation/ review, Completion Guidelines creation/ review, UAT (Screens and Edit Checks). Conduct and Close out: Protocol Deviation, Data Review Plan, Reconciliations, Change Control (Revision request), Query Management, Listings review, Dataset review, LAB Data review, Closeout Activities, Archiving (TMF) Education: Bachelor\'s degree and / or other medical qualifications or relevant industry experience. Certification or involvement in a professional society or organization is recommended. Location (Office Based) : Bengaluru/Hyderabad/Chandigarh/Mohali

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