Clinical Data Manager - CDISC Expert

Obsidian; Toronto; On-site; CAD 83,000 - 124,000; Part time

Job summary

Obsidian in Toronto invites a Clinical Data Manager to own data generation workflows across protocols, datasets and clinical narratives. You will drive consistency and quality across the data room while guiding QA and AI-driven evaluation efforts.

The role requires 5+ years in clinical data management, hands-on CDISC/SDTM experience, and EDC builds through database lock, with a strong focus on cross-file integrity and data traceability.

Qualifications

• 5+ years of clinical data management experience.
• Hands-on CDISC and SDTM conformance work.
• Experience with EDC build through database lock.
• Ability to enforce cross-file consistency between raw data, TLFs, and narratives.
• Leadership oversight of entire clinical data rooms.

Responsibilities

• Own data generation across protocols, datasets, TLFs and narratives.
• Lead QC and task authorship for synthetic data room.
• Design prompts, rubrics and metrics for AI evaluation.
• Ensure data integrity and cross-file consistency.
• Collaborate with cross-functional teams to meet timelines.

Skills

Leadership

CDISC

SDTM

Data management

EDC build

Quality assurance

Tools

EDC platforms

Data mapping

Job 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.