Clinical Data Manager / CDISC

As a clinical data manager on this project, you would own a part in multiple workflows:

1. Clinical Data Generation: you would lead it. We need someone who understands the entire anatomy of a data room and can guarantee that every artifact reconciles across the protocol, the datasets, the TLFs, and the narratives.

2. Data room QC and task authorship: you must be capable of validating a synthetic data room for realism, internal consistency, and traceability, and designing prompts, golden outputs, and rubrics to quantify the ability of an AI agent attempting to do the same thing.

To be qualified for this role, you must fit the following requirements:

Location: US, Canada, or France.

YOE: 5+ required. 10-25 preferred.

Education: no degree requirement. Experience is the gate for this role.

Hourly availability: 20-25 hours/week, minimum. 30+ STRONGLY preferred.

Experience: MUST have held managerial oversight of entire clinical data rooms, with hands-on CDISC and SDTM conformance work and EDC build through database lock. Comfortable enforcing cross-file consistency, so that a patient referenced in raw data appears correctly in the TLFs and folded metrics.