Senior Medical Data Specialist (Park Ridge, NJ)

Job Responsibilities:
-Works collaboratively with Study Director and Data Management in identifying Safety data concerns
-Ability to perform clinical data review like aggregate AE data review, and narrative writing which include but not limited to review of demographics, medical history and the events that meet narrative writing for CSR submission -Reviews appropriate codes of reported terms in clinical trials not limited to adverse events, medical history and medications
-Quantitative analysis – Performs a comprehensive review of efficacy and safety data
-Qualitative analysis – Ensures that SAE reconciliation of data fields and content are similar
-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 Clinical trial setting
-- At least 3 years of Clinical/ Safety Data Review and minimum 1 year coding required
-Knowledge of J-review, Central coding, Ds Navigator , INFORM a plus - Strong knowledge of ICH guidelines, proficiency on all related regulations, GCP, and Good Clinical DM Practice

Type: Long-term Contract