
Clinical Data Specialist
1 semana atrás
The role of Clinical Data Coder is to support the coding of clinical data for ongoing studies. This position will also participate in various clinical data management activities ensuring accurate and secure data capture, collection, and reporting.
- Accurate coding of medical terms and medications utilizing industry-wide standards such as MedDRA and WHO Drug.
- Coordinate dictionary assignment for meeting study requirements.
- Develop and maintain coding guidelines.
- Review and provide input on the Coding section of the Data Management Plan.
- Perform Dictionary up-versioning and Synonym List upgrade.
- Validate/test coding setup and programming of coding reports.
- Conduct data review.
- Write and resolve data clarifications.
- Understand and comply with core operating procedures and work instructions.
- Meet assigned objectives.
- Maintain good communications and working relationships with the DM team.
- Bachelor's degree or equivalent in pharmacy, life sciences, or related field or medical, nursing qualification with 2 years relevant experience.
- Thorough knowledge of Medical Terminology.
- Thorough knowledge of Medical Dictionaries used for coding.
- Experience working with clinical trials or within the pharmaceutical environment preferred.
- Demonstrate understanding and experience in query management process.
- Ability to work flexibly on simultaneous projects and manage time proactively.
- Excellent written and verbal English communication skills.
- Ability to work in a global team environment.
- Excellent organizational and analytical skills and high attention to detail.
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
- Flexible work schedule.
- Home-based position.
- Ongoing learning and development opportunities.
Indero is a contract research organization specialized in dermatology and rheumatology. Since its beginnings, our organization has built a strong reputation for delivering high-quality research and services that exceed client expectations. We continue to grow and expand across North America and Europe.
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