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Clinical Data Coder 2

Job ID 70818BR Bengaluru, Karnataka, India
• Perform the clinical coding mapping using coding dictionaries and map to the nearest Lowest 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 work status updates regularly 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.
• Generate Unique Terms Report (UTR)
• Assist in coding tool set up for the assigned trials
• Support in creation and central filing of clinical study documents which includes Coding conventions, coding definitions, coding configuration specification etc.
• Execution of User Acceptance Testing
• Assist in Technical peer review and functional QC activities of coding set up
• Support in archival of Clinical Study Documents in eTMF systems as appropriate
• Support with dictionary upgrade process
• Report any discrepancies observed with clinical dictionary used
• Report any issues with DBL process and related documentation.
• Assist in Database Lock activities
• Comply with Applicable SOPs, manuals trainings and best practices.
• Compliance to ICH-GCP
• Assist in developing/Updating the metrics/ dashboard for coding
• Performing/ Leading functional Coding activities
• Act as single point of contact for coding (primary coder) for assigned studies
• Support site monitoring personnel to retrieve coding as required
• Liaise with other support function to resolve any EDC to coding tool synchronization issue or vice versa.
• Ensure that all the scheduled timelines are met for the assigned studies
• Any issues related to coding should be proactively brought to the notice of LMs, Reviewers and study teams.
• Assist in training/mentoring new joiners

Qualifications

• Must be able to demonstrate expertise with several tasks included in coding set-up through study conduct.
• Solid understanding of clinical trials methodology and terminology required
• Basic knowledge of medical terminology
• Relevant experience in clinical coding
• Good knowledge of MedDRA and WHODD coding dictionaries
• Good knowledge of latest FDA and other applicable regulatory guidelines.
• Commitment and performs consistent high quality work
• Competent in written and oral English. Excellence in regional languages as needed.
• Must be able to demonstrate proficiency with several tasks included in study start-up through database lock.
• Previous relevant coding, data management work experience required; clinical and/ or research experience with solid understanding of clinical trials methodology and terminology required
• Bachelor’s degree and/ or other medical qualification or relevant coding or Data Management experience

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