Job Title: Clinical Trial Consultant II

Location: Cambridge, MA- Hybrid (2 days onsite)/open 100% remote

Duration: 1+ Year

Number of Hours per week: 40 per weeks



Job Scope: Responsible for case processing and/or QC of clinical trial ICSRs and postmarket case processing from sanctioned countries.

Key Responsibilities:

• Triage, Intake, case entry and QC of ICSRs originating from *** sponsored studies or other assigned cases

• Includes 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 an...