Medical Data Specialist (Park Ridge, NJ)

Primary Responsibilities:
-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
-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
-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

Qualifications:
-Medical Degree, Physician-Assistant or PharmD or graduate of adequate health care related course with commensurate experience in use of dictionaries in a clinical trial setting
-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 Central coding, Ds Navigator , INFORM a plus - proficiency in all related regulations, GCP, and Good Clinical DM Practice
-Computer proficiency and knowledge of medical terminology
-Strong Excel skills
-Strong oral and written communication skills

Type: Contract-to-hire