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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

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


• 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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