Clinical Data Manager, CDISC

Role Overview Lead clinical data generation and quality assurance across complete clinical data rooms, ensuring every artifact aligns from protocol through datasets, TLFs, and narratives. Key Responsibilities Lead clinical data generation workflows across multiple workstreams. Ensure reconciliation and traceability across protocols, datasets, TLFs, narratives, raw data, and derived metrics. Validate synthetic clinical data rooms for realism, internal consistency, and traceability. Create evaluation materials, including prompts, gold-standard outputs, and scoring rubrics, to measure an AI agent''s ability to validate clinical data rooms. Qualifications At least 5 years of relevant experience required, with 10 to 25 years preferred. Experience is required; no degree is required. Prior managerial oversight of entire clinical data rooms. Hands-on experience with CDISC and SDTM conformance, as well as EDC build through database lock. Ability to enforce cross-file consistency, including accurate representation of patients from raw data through TLFs and derived metrics. Work Terms Remote, hourly engagement. Minimum availability of 20 to 25 hours per week; 30 or more hours per week is strongly preferred. Compensation $100 to $150 per hour. Eligibility Applicants must be located in the United States, Canada, or France.