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

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