Coding Specialist II

Job description

Job Overview: Assisting with the data management leadership on a large / global project, or multiple projects with responsibility for the Thesaurus Management; and technical oversight of all dictionary coding activities for the delivery of medical coded data according to Fortrea/client quality and integrity specifications, and project timelines and budgets. Develop and maintain a close liaison with project Lead Data Reviewer, core team members, and Clinical Lead Data Managers as appropriate. Summary of Responsibilities: • Perform the clinical medical data coding aspects of assigned projects on a global basis independently. • Work with the Manager and aide in personal career development, interpersonal skills, and achievement of competency standards. • Assist with the identification and implementation of solutions to project data management coding issues and concerns. • Serve as the project liaison including provision of project specific coding status. • Assist in review of Data management plan (wherever coding sections are applicable) and/or Study specific Dictionary Coding Conventions and Specifications. • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, Clinical Data Management, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality of coded clinical data. • Assist in development and implementation of global SOPs and Work Instructions within functional area; liaise with other disciplines in the development of SOPs that impact functional area. • Maintain coding technical competencies via participation in internal and external training seminars. • Support project staff on achieving client satisfaction (internal and external) through delivery of quality medical coded data, on-time, and on-budget. • Assist in identifying areas for process improvement, efficiency improvement and implement solutions on assigned projects. • Assist with the dictionary verification of Fortrea standard dictionaries and client dictionaries in a timely manner. • Perform dictionary verification on assigned projects. • Review literature and research technologies/procedures for improving global thesaurus management practices. • All other duties as needed or assigned. Qualifications (Minimum Required): • University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., professional registered nursing certification, medical or laboratory technology). • Fortrea may consider relevant and equivalent experience in lieu of educational requirements. • Fluent in English, both written and verbal. Experience (Minimum Required): • Minimum (5-7) years relevant work experience in clinical data coding experience (MedDRA and WHODrug). • In-depth knowledge of medical coding process and various coding tools (e.g., Medidata Coder, Central Coding, etc.). • Demonstrated interpersonal skills. • Excellent oral and written communication and presentation skills. • In-depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations. • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies. • Broad knowledge of thesaurus management process. • Thorough knowledge of Standard Coding Dictionaries. • Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to medical coding of clinical data. • Knowledge of effective clinical data management practices. Preferred Qualifications Include: • MedDRA Certified. • Knowledge of Fortrea and the overall structure of the organization. • Thorough knowledge of Fortrea standard operating procedures and work instructions. Physical Demands/Work Environment: • Office or home-based work environment. • Travel Requirements: Regional % Of time:5 % Of the above that requires overnight stay: 50 Travel is primarily to where: Varies Learn more about our EEO & Accommodations request here.