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

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Coding Specialist II