Clinical Data Manager / CDISC | $100-$150/hr Remote
Overview
In this contract role, you will lead clinical data generation for an AI evaluation project. You'll apply CDISC and SDTM standards to build synthetic data rooms and keep every artifact consistent across protocol, datasets, TLFs, and narratives. Your output includes prompts, golden outputs, and rubrics that score how well an AI agent performs the same data management activities. The role requires 20-25 hours per week, with 30+ preferred, and candidates must reside in the US, Canada, or France.
What You'll Do8
- 1Lead the end-to-end generation of clinical data, covering protocol, raw datasets, TLFs, and narrative documents.
- 2Enforce cross-file consistency so a patient record in raw data matches the same values in derived metrics and TLF outputs.
- 3Validate synthetic data rooms for realism, internal consistency, and traceability against the original protocol.
- 4Author evaluation tasks, including prompts, golden outputs, and rubrics that score an AI agent's data management attempts.
- 5Review datasets for CDISC SDTM conformance, from raw input through EDC build and database lock.
- 6Reconcile artifacts across the data room, flagging any mismatches in patient-level or aggregate data.
- 7Design quantitative quality measures for AI agent performance based on the rubric outcomes.
- 8Provide managerial oversight of the full data room lifecycle, ensuring each deliverable aligns with regulatory and formatting expectations.
Requirements7
- 15+ years in clinical data management, with 10-25 years preferred for senior-level fit.
- 2Hands-on CDISC SDTM conformance work and experience building EDC systems through database lock.
- 3Prior managerial oversight of complete clinical data rooms, including protocol, datasets, TLFs, and narratives.
- 4Ability to enforce cross-file consistency across raw patient data, derived metrics, and TLF outputs.
- 5Based in the US, Canada, or France.
- 6Available 20-25 hours per week minimum, with 30+ hours strongly preferred.
- 7No formal degree required; practical experience is the primary qualification.
Who Should Apply
The ideal candidate is a clinical data manager who has owned entire data rooms and can trace a patient identifier from EDC through to final TLFs. If you have years of CDISC SDTM conformance work and know what database lock demands, this role lets you convert that expertise into evaluation tasks for an AI system. The role is less suitable for analysts who have only touched a single dataset or domain without cross-file accountability. Rejection often comes from a lack of managerial oversight evidence or from missing concrete examples of reconciling protocol-to-TLF mismatches. Applicants who cannot commit to 30 hours per week also see lower fit scores.
Salary Insight
Pay is $100-$150 per hour, billed on an hourly basis. The top end of that range aligns with the 10-25 year experience profile the project prefers.
Location
Required Skills
Application Tip
Include a one-page example of a data room you managed, showing how you reconciled a patient-level discrepancy between SDTM datasets and TLFs. Name the specific CDISC domains you handled and note whether you took the project through database lock.
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1Application received
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We check your profile against the role’s skills, seniority, and requirements.
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