- A graduate of allied health care related course with commensurate experience in data management
- Minimum of 5 years coding experience required
- At least 2 years of Coding in Clinical Research/Data Management.
- Strong knowledge of ICH guideline, or adequate background and have attended seminars for MedDRA and WHODD use
- Knowledge of coding tool Central coding, INFORM a plus
- Proficiency on all related regulations, GCP, and Good Clinical DM Practice
- Computer proficiency and knowledge of medical terminology
- Expertise on use of Excel
- Strong oral and written communication skills
We are looking for someone who is enthusiastic and willing to take a challenge in a fast growing company. Willing to explore further understanding of Clinical development from Data base design to Day to Day data Cleaning until Regulatory Submission.
Responsible for the selection codes using MedDRA and WHODD terminologies, which most accurately describe each panel according to established coding guidelines and conventions
Responsible for review of appropriate codes of reported terms in clinical trials not limited to adverse events, medical history and medications. Ensures that the term is clear, appropriate and complete as per investigator’s entry on the CRF otherwise, he/she is responsible for the coding query.
Familiar with grouping of terms for Adverse events of special interest or prohibited medications in a clinical trial setting.
Quantitative analysis – Performs a comprehensive review for the all the reported terms and coding assignments To assure the presence of all coding hierarchy in the CRFs not limited to LLT, PT and SOC and Trade name, Preferred Name ATC 2 and ATC 4 and their respective dictionary versions.
Qualitative analysis – Evaluates the record for coding consistency and adequacy. Ensures that the selected codes accurately reflect the term as provided by the investigator. Reviews the codes for ICH compliance and adherence to coding guidelines and conventions. Adequate Clinical Data review.
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