Clinical Data Manager, CDISC, SDTM

Job not on LinkedIn

🔥 0 minutes ago

🌐 United States, Canada, +1 more countries – Remote

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🗽 New York – Remote

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💵 $90 - $140 / hour

⏱ Part Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Logo of 24-MAG

24-MAG

2 - 10 employees

🤝 B2B

💼 Consulting

B2B • Consulting

24-MAG is a commercial strategy and execution firm that helps B2B organizations design and implement systems, workflows, and operating rhythms for sales, client management, and cross-functional projects. They focus on transforming scattered processes into aligned, measurable, and scalable commercial functions—covering pipeline structure, account management frameworks, and operational discipline for teams seeking efficient, intentional growth.

📋 Description

• 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 • Review complete clinical data rooms for realism, internal consistency, and traceability • Ensure information reconciles across protocols, raw datasets, derived datasets, TLFs, and narratives • Verify patient-level data flows correctly across downstream outputs • Identify discrepancies between source information and summary metrics • Apply CDISC and SDTM standards to datasets, variables, domains, controlled terminology, and conformance • Review EDC design, build, validation, CRF structures, edit checks, data-entry logic, and downstream data flow • Evaluate data-cleaning and reconciliation workflows and assess readiness for database freeze and lock • Verify consistency between patient records, datasets, TLFs, narratives, and summary outputs • Validate synthetic data rooms for completeness, realism, and professional quality • Evaluate data lineage and evidence provenance across data packages • Design realistic clinical data-management tasks based on authentic workflows • Develop prompts, expected outputs, evaluation criteria, and authoritative reference solutions • Define standards for correctness, traceability, and completeness

🎯 Requirements

• 5+ years of professional clinical data management experience; 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 • Must work 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

🏖️ Benefits

• Part-time independent contractor engagement • Fully remote • Minimum availability of approximately 20–25 hours per week • Availability of 30+ hours per week strongly preferred • Flexible scheduling based on project requirements • Projects may be extended, shortened, or concluded based on project needs and performance

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