Remote | Clinical Data Manager (CDISC & SDTM) — $90–$140/hour

We 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 Responsibilities Clinical Data Generation Lead the generation and validation of high-quality synthetic clinical trial data Ensure data structures reflect realistic clinical development and data-management workflows Review patient-level records for completeness, consistency, and plausibility Maintain alignment between protocol requirements and generated datasets Identify inconsistencies or missing relationships across clinical data artifacts Clinical Data Room Oversight Review complete clinical data rooms for realism, internal consistency, and traceability Ensure information reconciles across protocols, raw datasets, derived datasets, TLFs, and narratives Verify that patient-level data flows correctly across all downstream outputs Identify discrepancies between source information and summary metrics Apply end-to-end data-management judgement rather than reviewing files in isolation CDISC & SDTM Conformance Apply hands-on knowledge of CDISC and SDTM standards Review dataset structures, variables, domains, controlled terminology, and conformance Identify mapping, formatting, and traceability issues Evaluate whether transformed datasets accurately reflect underlying source data Support consistent application of standards across study-level data packages EDC Build & Database Lifecycle Apply experience across EDC design, build, validation, and study conduct Review CRF structures, edit checks, data-entry logic, and downstream data flow Evaluate data-cleaning and reconciliation workflows Assess readiness for database freeze and lock Identify unresolved issues that could compromise final data integrity Cross-File Reconciliation Verify consistency between patient records, datasets, TLFs, narratives, and summary outputs Ensure participants referenced in one artifact are represented correctly across related files Identify mismatched values, missing records, inconsistent denominators, or contradictory outputs Assess whether folded or aggregate metrics reconcile to patient-level data Maintain traceability from source data through final reporting outputs Data Room Quality Control Validate synthetic data rooms for completeness, realism, and professional quality Identify implausible clinical-data patterns or inconsistencies Review whether expected artifacts are present and appropriately linked Evaluate data lineage and evidence provenance across the data package Apply a verify-before-finalise approach to all major outputs Task & Reference Output Development Design realistic clinical data-management tasks based on authentic workflows Develop clear prompts, expected outputs, and evaluation criteria Produce authoritative reference solutions for data-room and reconciliation tasks Define standards for correctness, traceability, and completeness Create tasks that reflect how experienced clinical data managers work in practice Ideal Profile 5+ years of professional clinical data management experience , with 10–25 years preferred Demonstrated managerial oversight of complete clinical data rooms Strong hands-on expertise with CDISC and SDTM conformance Experience managing EDC workflows from build through database lock Strong understanding of clinical datasets, TLFs, narratives, and cross-file reconciliation Ability to identify inconsistencies across patient-level and aggregate data Experience ensuring traceability across protocols, datasets, outputs, and reporting artifacts Strong knowledge of clinical data lifecycle, cleaning, validation, and database closeout Comfortable leading complex data-quality and reconciliation workflows No specific degree is required; substantial hands-on experience is the primary qualification Strong written communication and ability to document data-quality findings clearly Based in the United States, Canada, or France Engagement Details Part-time independent contractor engagement Fully remote Minimum availability of approximately 20–25 hours per week Availability of 30+ hours per week is strongly preferred Flexible scheduling based on project requirements Compensation: $90–$140/hour Work may include clinical data generation, data-room QC, CDISC/SDTM validation, reconciliation, and task development Projects may be extended, shortened, or concluded based on project needs and performance Work must be completed without using confidential or proprietary information belonging to any employer, sponsor, client, institution, or other third party H1-B and STEM OPT support is unavailable for this engagement About the Platform This opportunity is available through 24-MAG LLC. 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