Clinical Data Manager, CDISC, SDTM

This is a fully remote position, open to applicants in United States, +3 more locations.

📋 Description

• Lead the creation and validation of high-quality synthetic data for clinical trials.

• Ensure that data structures accurately reflect realistic workflows in clinical development and data management.

• Review patient-level records to assess completeness, consistency, and plausibility.

• Maintain congruence between protocol requirements and the datasets generated.

• Identify discrepancies or missing connections within clinical data artifacts.

• Examine complete clinical data rooms for realism, internal coherence, and traceability.

• Ensure information is consistent across protocols, raw datasets, derived datasets, TLFs, and narratives.

• Verify that patient-level data is accurately transmitted across downstream outputs.

• Identify inconsistencies between source data and summary metrics.

• Apply CDISC and SDTM standards to datasets, variables, domains, controlled terminology, and compliance.

• Review EDC design, development, validation, CRF structures, edit checks, data-entry logic, and downstream data flow.

• Assess data-cleaning and reconciliation workflows to determine readiness for database freeze and lock.

• Ensure consistency among patient records, datasets, TLFs, narratives, and summary outputs.

• Validate synthetic data rooms for completeness, realism, and professional quality.

• Evaluate data lineage and provenance evidence across data packages.

• Design realistic clinical data-management tasks based on authentic workflows.

• Develop prompts, expected outcomes, evaluation criteria, and authoritative reference solutions.

• Establish standards for correctness, traceability, and completeness.

⛳️ Requirements

• Over 5 years of professional experience in clinical data management; 10–25 years preferred.

• Proven managerial oversight of complete clinical data rooms.

• Strong practical expertise in CDISC and SDTM compliance.

• Experience managing EDC workflows from development through database lock.

• Deep understanding of clinical datasets, TLFs, narratives, and cross-file reconciliation.

• Ability to identify inconsistencies in both patient-level and aggregate data.

• Experience ensuring traceability across protocols, datasets, outputs, and reporting artifacts.

• Strong knowledge of the clinical data lifecycle, including cleaning, validation, and database closeout.

• Comfortable leading intricate data-quality and reconciliation workflows.

• No specific degree is required; significant hands-on experience is the main qualification.

• Excellent written communication skills and the ability to document data-quality findings clearly.

• Must be based in the United States, Canada, or France.

• Must be able to work without accessing confidential or proprietary information from any employer, sponsor, client, institution, or other third party.

• H1-B and STEM OPT support is not available for this position.

🏝️ Benefits

• Engagement as a part-time independent contractor.

• Fully remote position.

• Minimum availability of approximately 20–25 hours per week.

• Preference for availability of 30+ hours per week.

• Flexible scheduling based on project needs.

• Projects may be extended, shortened, or concluded based on project requirements and performance.