Clinical Data Manager, CDISC

Role Overview

Lead clinical data generation and quality assurance across synthetic clinical data rooms, ensuring every artifact reconciles across protocols, datasets, tables, listings, figures, and narratives. This role also develops evaluation materials to measure an AI agent''s ability to validate clinical data rooms.

Key Responsibilities

• Lead clinical data generation workflows and oversee the full structure of a clinical data room.
• Ensure consistency and traceability across protocols, datasets, tables, listings, figures, narratives, and related metrics.
• Validate synthetic data rooms for realism, internal consistency, and traceability.
• Create prompts, expected outputs, and scoring rubrics for evaluating AI-led data-room validation.
• Enforce cross-file consistency, including accurate representation of patients from raw data through tables, listings, figures, and derived metrics.

Qualifications

• At least 5 years of relevant experience required; 10 to 25 years preferred.
• No degree is required; demonstrated experience is the deciding qualification.
• Prior managerial oversight of complete clinical data rooms.
• Hands-on experience with CDISC and SDTM conformance, plus EDC build activities through database lock.

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.