Clinical Data Coder I

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