Responsible for the selection and 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.
Abstracts all necessary information from other CRF pages for concept coding if necessary.
Assigns codes using MedDRA and WHODD terminologies, which most accurately describe each panel according to established coding guidelines and conventions.
Performs reconciliation of safety report and clinical patient profile.
Performs a comprehensive review for the all the reported and coded terms. To assure the presence of all coding targets 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.
Ensures all safety reports are reconciled in the clinical database.
Graduate of adequate health care related course with commensurate experience in use of dictionaries in Clinical trial setting and have performed clinical data review.
Minimum of 5 years coding experience required as well as AE/SAE data review.
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 Central coding, Ds Navigator , INFORM a plus
Expertise on use of Excel
Proficiency on all related regulations, GCP, and Good Clinical DM Practice
Computer proficiency and knowledge of medical terminology
Associated topics: biomedical, dietary, drug, drug development, food, immunohematology, injury, microbiology, nephrology, pharmacology