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