Clinical Data Manager / CDISC

Official role description

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.