Job
Description
As a Clinical Data Coder 1 specializing in MedDRA and WHODD, with 2-5 years of work experience, your primary responsibility will be to provide comprehensive data management expertise to the Data Management (DM) team for meeting sponsor and company needs. You will be involved in performing Clinical Data Management and/or Coding activities, taking on leadership roles such as Lead Coder or Data Operations Coordinator (DOC) for specific CDM tasks, or leading coding tasks on mega trials. In this role, you will independently manage coding activities and projects throughout the full study life-cycle, ensuring high quality and timely delivery with minimal guidance. Your responsibilities will include validating and testing coding applications and reports, conducting data review, resolving data clarifications, and managing coding project timelines under the guidance of the DOC or Data Team Lead (DTL). Additionally, you will be involved in Serious Adverse Event (SAE) reconciliation activities, performing quality control procedures, and assisting in the implementation of new technology related to coding and data management. You will also be expected to handle audit requirements for studies, maintain compliance with core operating procedures and work instructions, and collaborate effectively with the study team. To excel in this role, you should hold a qualification in Pharmacy, dental, medical, nursing, life sciences, or a related field, with excellent knowledge of medical terminologies, pharmacology, anatomy, and physiology. You should possess in-depth knowledge of medical dictionaries such as MedDRA and WHODD, and have a solid understanding of the Data Management process from study start-up to database lock. Your ability to bring coding and project-related solutions to the DM team, maintain good communication within the team, and adapt to changing requirements will be crucial for success in this position. Your dedication to meeting objectives as assigned, along with your attention to detail and commitment to quality, will contribute to the overall success of the data management processes within the organization.,
