Clinical Trial Consultant II

Clinical Trial Consultant IICambridge, 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 ResponsibilitiesTriage, intake, case entry, and QC of ICSRs originating from client-sponsored studies or other assigned casesPerform narrative writing, MedDRA coding, drafting of follow-up queries, and event notifications to internal stakeholdersPerform retrospective quality checks on processed casesIndependently 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 reportingReview and resolution of reconciliation issues between the clinical and safety databases in collaboration with Data ManagementProvide investigation details into late regulatory reporting of CT casesEducation and ExperienceBachelor's degree in a science or healthcare-related field4+ years of experience in pharmacovigilanceKnowledge and SkillsKnowledge of global and local safety regulationsExcellent written and verbal communication skillsExperience in ICSR processing in safety database systems such as ArisG, Argus, and VeevaUnderstanding of global safety reporting regulations and guidelines including FDA, ICH, and EU Regulations and Requirements for PharmacovigilanceStrong 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

Created: 2026-05-13