Clinical Data Coder 1

2 weeks ago

Remote, India Parexel Full time

The role of the Clinical Data Coder I (CDC I) is to perform assigned tasks or activities in clinical data
coding. Activities may include coding of clinical data, generation and integration of queries, and running of reports under supervision of senior coding staff and/or line manager. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements

Perform the clinical coding mapping using coding dictionaries and map to the nearest Low Level Term (LLT) or Drug Name as the case may be.

Identify the verbatim that are ambiguous and issue queries in line with applicable coding conventions.

Provide regular work status updates to direct supervisor or primary coder and sponsor

Support as back-up in absence of primary coder

Provide inputs for process improvement

Identify and report issues with coding and EDC system synchronization.

Assist in coding tool set-up for the assigned trials

Author or review Coding Documents which includes Coding conventions, coding definitions, coding configuration specification etc.

Assist in execution of User Acceptance Testing

Assist in Technical peer review and functional QC activities of coding set up

Ensure coding-owned documents are placed in eTMF systems as appropriate

Generate Unique Terms Report (UTR)

Report any discrepancies observed with clinical dictionary used

Report any issues with DBL process and related documentation.

Ensure that all the scheduled timelines are met for the assigned studies

Any issues related to coding should be proactively brought to the attention of LMs, Reviewers and study teams.

Comply with Applicable SOPs, manuals trainings and best practices.

Compliance to regulatory requirements (e.g. ICH-GCP)

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