Sr. Coding Specialist - Teva Pharmaceuticals (west chester, pennsylvania) in Philadelphia, Pennsylvania For Sale

Primary purpose and function of this position: We are seeking a candidate with recent clinical trials coding experience and a healthcare background (RN preferred) that is interested in moving beyond the role of A?coderA? to a specialist in our outsourced coding model primarily responsible for vendor oversight management and stakeholder support. Your background, expertise and knowledge of MedDRA and WHODrug will provide higher level quality reviews of coding for programs of studies to ensure data is consistent and compliant with standards and guidelines. You will participate on a team that is involved in multiple stages of clinical trials and be a part of developing creative, innovative approaches for process improvement. Our multifunctional study team approach is challenging and globally interactive, allowing opportunities for knowledge sharing and close collaboration with study clinicians and peers. The Senior Coding Specialist will serve as a coding lead for assigned clinical studies, ensure creation of Medical Coding Plan (MCP) at study start:up, and will provide Quality Control (QC) review of coding provided by outsourced service providers. Additionally, the Senior Coding Specialist will assist management with improving and maintaining the coding database infrastructure, processes and may mentor/train other medical coding staff. WHODrug and MedDRA Required. Major duties and responsibilities:Oversees all coding activities performed by service providers for assigned studies. Performs in:house coding as needed.Ensures accurate coding of medical terminology using MedDRA and WHODrug or other company coding tools in accordance with company coding conventions, process, SOPs and regulatory requirements.Leads medical coding startup activities which include creation of the Medical Coding Plan and may involve consulting with the Clinical Project Physician (CPP) or their designee.Serves as coding lead for active clinical trial(s) and/or therapeutic group of studies for assigned trials.Overall responsible for delivering accurate and consistent medical coding for all assigned company protocols within established timelines and in compliance with processes, guidelines and conventions. Attends study team meetings with proactive interaction with stakeholders across functional areas to ensure coded data is captured appropriately, approved and delivered within established timelines.Performs QC of coding outsourced to service providers. Identifies and provides requests for data clarification for data that cannot be coded and coding change requests, if necessary.Develops positive partnerships with CROs and ensures a high standard of deliverables are maintained.Collects and monitors study coding metrics.Provides feedback/guidance to service providers, CPP, and Data Management to assist in the resolution of coding issues.Coordinates reviews by the CPP during the study and facilitate the generation of queries for questions raised after medical review.Provides coding/dictionary information as requested to the CPP to facilitate coding review and medical monitoringDiscusses final coding with the CPP and facilitates the coding approval process to ensure coding is approved prior to interim and final database clean/lock activities.Ensures all coding is complete and without discrepancies prior to database clean/lock and documentation is stored in relevant folders. Assists in maintenance activities for coding databases, including version upgrades, enhancement of coding algorithm and synonym tables.Assists in development of SOPs and coding processes.Mentors more junior coders and assists in training activities when applicable.Follows Teva Safety, Health, and Environmental policies and procedures.Conducts other projects and tasks as assigned. Reports To: Head of Dictionary ManagementEducation and Knowledge Requirements:Senior Coding Specialist must have 5 or more years of medical coding experience in a pharmceutical or clinical research setting (3 or more
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