Clinical Data Coder I

5 days ago

Bengaluru Karnataka, India Parexel Full time

**Clinical Data Coder I**

The role of the Clinical Data Coder I (CDC I) is to perform assigned tasks or activities in clinical data coding with 2 to 4 years of experience. 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.

**Clinical Coding**
- 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.

**Coding Set up, Reports and Documentation**
- 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)

**Dictionary Management and Database Lock**
- Report any discrepancies observed with clinical dictionary used
- Report any issues with DBL process and related documentation

**Project Management & Compliance**
- 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)

**Skills**:

- Ability to work and collaborate in team environment
- Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
- Demonstrates attention to detail and commitment to First Time Quality, including a methodical and accurate approach to work activities
- Good Interpersonal, verbal and written communication skills
- Demonstrates analytical and problem-solving skills, including ability to conduct root cause analyses
- Written and oral fluency in English

**Knowledge and Experience**:

- Strong knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODrug)
- Knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs), Microsoft Office products
- Understanding of Data Management processes and data flows
- Demonstrated experience in clinical coding
- Understanding of regulatory requirements (e.g. ICH-GCP)
- Basic knowledge regarding the QC and Set-Up, Conduct, and Close-Out of Coding Systems and Tools.

**Education**:

- Bachelor’s degree and/ or other medical qualification or relevant coding or Data Management experience

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