Requirements

Must have at least 5 years of coding and clinical data review experience who can support one of our submissions.
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 Case Report Form otherwise, he/she is responsible for the coding query.
Abstracts all necessary information from other Case Report Form 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.
Post queries for relevant information from safety report to be added in the clinical database.
May require narrative writing for clinical data review profile.
Quantitative analysis 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.
Completes brief description of clinical cases for clinical data review utilizing the autogenerated narratives.
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.
Performs all duties according to company policy and regulations and guidance.
Performs other duties assigned by the Director or Sr. Manager.
No travel required.

Responsibilities

Selection and review of codes for reported terms in clinical trials including adverse events, medical history and medications.
Abstracts necessary information from other Case Report Form pages for concept coding when needed.
Assigns codes using MedDRA and WHO Dictionary terminology.
Performs reconciliation of safety report and clinical patient profile.
Post queries for safety information to be added in the clinical database; may require narrative writing for clinical data review profiles.
Conducts quantitative analysis by reviewing all reported and coded terms ensuring targets such as List of Coding Targets (LLT, PT, SOC, Trade name, Preferred Name, ATC 2, ATC 4) and respective dictionary versions are present; completes brief descriptions of clinical cases using autogenerated narratives.
Conducts qualitative analysis to evaluate coding consistency and adequacy; ensures codes reflect investigator term and comply with ICH guidelines and coding conventions.
Ensures reconciliation of all safety reports in the clinical database; adheres to company policy and regulations; performs other duties as assigned; no travel required.

Desired Qualifications

Knowledge of Central Coding, Ds Navigator, INFORM is a plus.
Proficiency in relevant regulations, Good Clinical Practice and Good Data Management Practice.
Strong knowledge of ICH guidelines, or adequate background and have attended seminars for MedDRA and WHODD use.
Graduate of health care related course with commensurate experience in use of dictionaries in clinical trial setting.

Senior Medical Data Specialist

Artech Information System

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