Clinical Data Manager

Specialised Part-Time Consulting OpportunityWe are sharing a specialised part-time consulting opportunity for experienced clinical data management professionals with deep expertise in CDISC standards, SDTM conformance, EDC build, database lock, and end-to-end clinical data room oversight.This role supports advanced clinical research workflows involving synthetic clinical data generation, data-room quality control, and cross-document reconciliation. Selected professionals will help ensure that protocols, datasets, tables, listings, figures, narratives, and downstream metrics remain internally consistent, realistic, and fully traceable.Key ResponsibilitiesClinical Data GenerationLead the generation and validation of high-quality synthetic clinical trial dataEnsure data structures reflect realistic clinical development and data-management workflowsReview patient-level records for completeness, consistency, and plausibilityMaintain alignment between protocol requirements and generated datasetsIdentify inconsistencies or missing relationships across clinical data artifactsClinical Data Room OversightReview complete clinical data rooms for realism, internal consistency, and traceabilityEnsure information reconciles across protocols, raw datasets, derived datasets, TLFs, and narrativesVerify that patient-level data flows correctly across all downstream outputsIdentify discrepancies between source information and summary metricsApply end-to-end data-management judgement rather than reviewing files in isolationCDISC & SDTM ConformanceApply hands-on knowledge of CDISC and SDTM standardsReview dataset structures, variables, domains, controlled terminology, and conformanceIdentify mapping, formatting, and traceability issuesEvaluate whether transformed datasets accurately reflect underlying source dataSupport consistent application of standards across study-level data packagesEDC Build & Database LifecycleApply experience across EDC design, build, validation, and study conductReview CRF structures, edit checks, data-entry logic, and downstream data flowEvaluate data-cleaning and reconciliation workflowsAssess readiness for database freeze and lockIdentify unresolved issues that could compromise final data integrityCross-File ReconciliationVerify consistency between patient records, datasets, TLFs, narratives, and summary outputsEnsure participants referenced in one artifact are represented correctly across related filesIdentify mismatched values, missing records, inconsistent denominators, or contradictory outputsAssess whether folded or aggregate metrics reconcile to patient-level dataMaintain traceability from source data through final reporting outputsData Room Quality ControlValidate synthetic data rooms for completeness, realism, and professional qualityIdentify implausible clinical-data patterns or inconsistenciesReview whether expected artifacts are present and appropriately linkedEvaluate data lineage and evidence provenance across the data packageApply a verify-before-finalise approach to all major outputsTask & Reference Output DevelopmentDesign realistic clinical data-management tasks based on authentic workflowsDevelop clear prompts, expected outputs, and evaluation criteriaProduce authoritative reference solutions for data-room and reconciliation tasksDefine standards for correctness, traceability, and completenessCreate tasks that reflect how experienced clinical data managers work in practiceIdeal Profile5+ years of professional clinical data management experience, with 10–25 years preferredDemonstrated managerial oversight of complete clinical data roomsStrong hands-on expertise with CDISC and SDTM conformanceExperience managing EDC workflows from build through database lockStrong understanding of clinical datasets, TLFs, narratives, and cross-file reconciliationAbility to identify inconsistencies across patient-level and aggregate dataExperience ensuring traceability across protocols, datasets, outputs, and reporting artifactsStrong knowledge of clinical data lifecycle, cleaning, validation, and database closeoutComfortable leading complex data-quality and reconciliation workflowsNo specific degree is required; substantial hands-on experience is the primary qualificationStrong written communication and ability to document data-quality findings clearlyBased in the United States, Canada, or FranceEngagement DetailsPart-time independent contractor engagementFully remoteMinimum availability of approximately 20–25 hours per weekAvailability of 30+ hours per week is strongly preferredFlexible scheduling based on project requirementsCompensation: $90–$140/hourWork may include clinical data generation, data-room QC, CDISC/SDTM validation, reconciliation, and task developmentProjects may be extended, shortened, or concluded based on project needs and performanceWork must be completed without using confidential or proprietary information belonging to any employer, sponsor, client, institution, or other third partyH1-B and STEM OPT support is unavailable for this engagementAbout the PlatformThis opportunity is available through 24-MAG LLC. 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