Clinical Trial Consultant II

Clinical Trial Consultant II at Hydrogen Group Clinical Trial Consultant II at Hydrogen Group in Winchester, Massachusetts Posted in 4 minutes ago.

Type:

full-time

Job Description:

Clinical Trial Consultant II Cambridge, MA - 2

Days Onsite Schedule:

Standard EST Hours Duration:

12-

Month Contract Pay:

$55-60/hr (W2) Our client is a leading global biopharmaceutical company focused on the research, development, and delivery of therapies for neurological and rare diseases. They are seeking a detail-oriented Clinical Trial Consultant II to support case processing and quality control of clinical trial ICSRs and post-market case processing from sanctioned countries. Essential Functions and Responsibilities Triage, intake, case entry, and QC of ICSRs originating from client-sponsored studies or other assigned cases Perform narrative writing, MedDRA coding, drafting of follow-up queries, and event notifications to internal stakeholders Perform retrospective quality checks on processed cases Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting Review and resolution of reconciliation issues between the clinical and safety databases in collaboration with Data Management Provide investigation details into late regulatory reporting of CT cases Education and Experience Bachelor's degree in a science or healthcare-related field 4+ years of experience in pharmacovigilance Knowledge and Skills Knowledge of global and local safety regulations Excellent written and verbal communication skills Experience in ICSR processing in safety database systems such as ArisG, Argus, and Veeva Understanding of global safety reporting regulations and guidelines including FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance Strong computer skills within the Microsoft Office suite (Word, Excel, PowerPoint, and Outlook) Knowledge of medical and clinical practices with a strong understanding of medical concepts and terminology