About this role
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.