What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
You look after the data from a clinical trial so it is complete, correct, and ready to analyse. The trial is the experiment; the data is the only thing that survives it.
You manage case report form data in the EDC, raise and resolve queries against defined edit checks, reconcile external data such as laboratory and safety feeds, and support database lock under GCP. ICH E6(R3) makes data governance across the record’s lifecycle a sponsor responsibility, so how a value was captured, changed and by whom is part of the evidence rather than metadata around it.
You protect the credibility of the evidence a regulatory approval will ultimately rest on. A trial with a strong protocol and weak data management produces conclusions nobody can defend at inspection — and by the time that is discovered, the subjects have already been dosed.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
In clinical data management, within clinical development.
- Source data capture at the site
- Protocol and CRF design
- Statistical analysis and submission
- Database lock
- Source records at the site
- A validated EDC system
- The protocol and data management plan
- Biostatistics
- Regulatory Affairs (for submission data)
- Query management and data reconciliation
- Data quality toward lock
- Treating participants
- Deciding the trial result
- Data management lead and clinical operations
- For a data-integrity issue or a safety-relevant discrepancy
- Query and reconciliation records
- Data management documentation for the trial master file
WHAT THIS ROLE CAN EVIDENCE · 1
Mapped to this role in the published registry. Nothing on this site assesses them yet, so this is what the standard says the work involves — never a claim about you.
A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Clinical Operations pathway, then Practise in a scenario, then what any of it evidences. Skip any of them — the order does not change.
ENTERPRISE CAPABILITIES YOU WILL ENCOUNTER
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- ICH E6(R3)Good Clinical Practice (GCP)ICH · last revised 2025-01-06
- ICH E8(R1)General Considerations for Clinical StudiesICH · last revised 2021-10-06
- 21 CFR Part 312Investigational New Drug Application (IND)FDA · last revised 2023-01-01
- 21 CFR Part 50Protection of Human Subjects (Informed Consent)FDA · last revised 2024-01-01