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.
