Senior Clinical Coding Specialist

Job Summary

Otsuka is a healthcare company driven by our purpose and defined by our beliefs. Otsuka DM is part of the Clinical Analytics department and supports the efficient and effective development and delivery of the clinical pipeline. The Sr. Clinical Coding Specialist represents the OPDC Data Management Department in a leadership role as a key member of the Global Medical Coding Working Group to govern global medical coding practices.

The Sr. Clinical Coding Specialist also provides technical expertise to coders, data managers, and project teams to develop and maintain consistency, accuracy and quality of data coding.

• Lead and manage end to end coding activities and deliverables across multiple projects.

• Serve as Coding Subject Matter Expert (SME) from protocol review to database lock to provide guidance for all dictionary related issues and strategies.

• Collaborate with global Otsuka affiliates to manage the up-versioning and recoding activities of all clinical data according to Otsuka up-versioning strategy.

• Maintain, up-version and distribute global synonym lists for clinical data.

• Provide consultation, leadership, and expertise to Contract Research Organization (CRO) personnel and internal Data Managers on coding processes.

• Maintain OPDC coding guidelines, updating as necessary with input from clinical and safety team members.

• Develop standard processes to be used for coding activities.

• Establish and maintain training documents related to coding practices.

• Work collaboratively with Information Technology team to maintain and upgrade existing coding technology, as well as evaluate new coding applications as needed.

• Provide expert review for Testing and Validation documents (eg. User Acceptance Test) as they relate to coding activities.

• Attend MedDRA and WHO Drug User group meetings to maintain currency with industry standards and perspectives.

• Proactively identify and implement opportunities for process improvements.

• Provide input in the development of departmental and global standard operating procedures (SOPs) and Working Practices (WPs).

• Review coding listings from CROs for consistency and appropriate assignment of codes.

• Provide resolution alternatives to data managers, reviewers and CROs for appropriate coding, based on assessment of industry coding and research.

• Collaborate with Clinical Development and Pharmacovigilance for review of coding listings.

• Coordinate with Biostatistical Programming and Data Management personnel to resolve coding related issues.

• Review Data Management Plans and approve Data Coding Conventions for CROs for OPDC trials as they pertain to clinical coding.

• Ensure consistency and accuracy of data coding across programs.

• Ensure completion of coding deliverables in accordance with timelines. Provide support in the development of CMQ’s and CDQ’s when requested by Pharmacovigilance, Global Clinical Development or Biostatistics.

• Other tasks as assigned.

• Extensive knowledge and skill in developing customized MedDRA queries (CMQs) and WHODrug Customized Drug Groupings (CDGs)

• Extensive knowledge and skill of coding with MedDRA and WHO Drug Dictionaries

• Ability to read, understand and interpret medical records and other treatment documentation

• Knowledge of medical and clinical practices with an understanding of medical concepts and terminology

• Solid knowledge of applicable U.S. regulatory requirements and a complete understanding of pharmaceutical industry practices

• High level of interpersonal, problem solving, and analytic skills

• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs

• Basic knowledge and understanding in working with sFTP file sharing systems

• Demonstrated knowledge in basic Clinical Data Management standard practices and functionality in clinical drug development

• Ability to establish and maintain collaborative working relationships with others

• Capacity to remain flexible, frequently re‑assessing and re‑prioritizing projects based on business needs

• Strong oral and written communication and presentation skills

• Strong attention to detail, problem solving and critical thinking skills

• Ability to…