job title: Coding specialist 2(fortrea)

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 (3-4) 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.

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