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 three (6-8) years relevant work experience in clinical data management with 2 years 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.
  
  

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