Clinical Trial Consultant II

Position:

Clinical Trial Consultant II Location:

140 6th St, Cambridge, MA 02142

Duration:

12-Month Contract (Potential Extension or Conversion to Full-Time)

Compensation:

$50.00 - $60.22/hr on W2

Benefits:

Weekly Pay, Medical, Dental, and Vision Coverage Work Schedule:

Hybrid - 3 Days Remote / 2

Days Onsite Job Summary:

The Clinical Trial Consultant II will be responsible for case processing and quality control (QC) of clinical trial ICSRs and post-market case processing from sanctioned countries.

Key Responsibilities:

Perform triage, intake, case entry, and QC of ICSRs originating from Client -sponsored studies and other assigned cases Prepare narratives, perform MedDRA coding, draft follow-up queries, and issue event notifications to internal stakeholders Conduct retrospective quality checks on processed cases Independently manage assigned cases, including weekend and holiday coverage, to ensure timely case completion and regulatory reporting Collaborate with Data Management to review and resolve reconciliation issues between clinical and safety databases Support investigations related to delayed regulatory reporting of clinical trial cases

Required Skills & Qualifications:

Strong knowledge of global and local safety regulations Excellent written and verbal communication skills Hands-on experience with safety databases such as ArisG, Argus, and Veeva Solid understanding of FDA, ICH, and EU pharmacovigilance regulations and reporting requirements Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) Strong understanding of medical terminology, clinical practices, and medical concepts

Education & Experience:

Bachelor's degree in Science, Healthcare, or a related field Minimum 4+ years of Pharmacovigilance experience #TMN