Job Details

Specialised Part-Time Consulting Opportunity

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. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.

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