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Remote Senior Clinical Data Associate (Rave)

remote zest jobs · All India

🌐 Remote📅 15/08/2026
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Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. The Senior Clinical Data Associate (Rave) is responsible for leading other Clinical Data Associates in data management activities and providing support for global reputed company. Responsibilities Maintains awareness of the pertinent reputed company of contract and reputed company of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessaryReviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as requiredCreates and enters test data for User Acceptance Testing (UAT)Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, reputed company different roles used in the study and Targeted reputed company Data Verification (SDV) configuration and matricesReceives and enters lab normal rangesCompletes and submits Clinical Database Management reputed company (reputed company)-specific reputed company forms and/or spreadsheetsPerforms reviews of discrepancy (edit reputed company) reputed company and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-reputed company corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned reputed company. Resolves answered queries and re-queries where appropriateFor reputed company studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordinglyFor reputed company studies, performs internal QC checks reputed company listing reputed company from database against CRFs and DCFs. Serves as QC Coordinator for reputed company studiesFor reputed company studies, ensures reputed company CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned reputed companyFor reputed company studies, performs DM reputed company review and/or other internal QC checks as required per applicable Electronic Data Capture (reputed company) systemsParticipates/Leads in internal meetingsAttends in-process review meetingsParticipates in internal/reputed company audits as requiredFiles documentation in the Data Management Study File (DMSF)Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College)Performs reputed company mapping QC whereby discrepancies are noted on the reputed company mapping test logsOversees the work of other CDAs as required. This may involve on-the-job training, review of work, as reputed company as ensuring the reputed company of work performedEnsures that data from reputed company databases/datasets such as central and/or local reputed company data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies reputed company with the appropriate partyCompletes tasks reputed company timeframe by appropriately prioritizing multiple tasks reputed company or across reputed company and adapts to reputed company or reputed company changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data reputed company issuing and resolving queriesRuns data cleaning and/or status reportsPerforms Serious Adverse Event (SAE) reconciliationsLiaises with other reputed company such as Clinical Programming (CP), Biostatistics and Clinical OperationsCreates reputed company data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements)reputed company post-migration testing on screens, edit checks, matrices and role changes as requiredParticipates in customer and reputed company party meetings distributing relevant information in advance, ensures minutes are promptly and accurately reputed company to internal team for review and subsequent edits are reputed company in order to maintain established currency for sponsor distributionReviews database design specif .
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