Roles & Responsibilities : -
- Creation of study specific coding related documents.
- Ensure Medication and Medical terminologies (Adverse event terms, Indication for use, causes of death, surgical history and medical history terms etc.) reported to clinical trials are consistently and precisely coded using MedDRA and WHO Drug dictionaries.
- Evaluate reported Medication and Medical terminologies to determine the need for clarification by the reporter and request data update where necessary.
- Ensure error free quality data with no open coding queries.
- Ensure closure of all reported errors and / or received coding comments by taking appropriate action.
- Ensure that datasets of coded terms are reviewed and provided to Global Data Manager for Study Physician Review.
- Perform continual monitoring of the coding for studies due for study milestones (e.g., Database Lock, Interim Analysis, DSUR, PSUR etc.)
- Point of Contact for study specific communication with internal and external stakeholders working on the same project / study.
- Participate / attend relevant study specific teleconference with the client
Skills Required
Evaluation, Life Sciences, Medical Terminology, Report Writing