- Perform the clinical medical data coding aspects of assigned projects with supervision
- Work with the technical service group staff and aide in personal career development, interpersonal skills, and achievement of competency standards
- Assist the technical leader on all coding aspects for project(s) including start-up, maintenance, and completion activities
- Serve as the project liaison including provision of project specific coding status
- Implement solutions to project data management coding issues and concerns under direction
- Assist in review of Data management plan (wherever coding sections are applicable) and/or Study-specific Dictionary Coding Conventions and Specifications
- 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
- Support the 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.
- Achieve client satisfaction through delivery of quality medical coded data, on-time and on-budget
- Maintain technical competencies via participation in internal and external training seminars
- Support locally-based project staff on achieving client satisfaction (internal and external) through delivery of quality medical coded data, on-time and on-budget
- Implement solutions for process and efficiency improvement on assigned projects
- Assist with the dictionary verification on assigned projects
- Review literature and research technologies/procedures for improving global thesaurus management practices
- Perform other duties as assigned by management
- 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)
- In lieu of the above requirement, approximately 24 months experience in related field (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately two to three (2-3) year’s clinical data coding experience in addition to the minimum four (4) years relevant work experience in data management will be considered
- Minimum two (2-3) years relevant work experience in data management
- Excellent oral and written communication and presentation skills.
- Basic knowledge of medical coding process and various coding tools (e.g. Medidata Coder, Central Coding, etc.)
- 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.
- Demonstrated interpersonal skills.
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