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Clinical Trial Consultant II

Tailored Management

Cambridge, MA

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JOB DETAILS
SALARY
$60.22 Per Hour
SKILLS
Clinical Data, Clinical Practices/Protocols, Clinical Trial, Communication Skills, Consulting, Data Management, FDA (Food and Drug Administration), Healthcare, ICH Regulations, Medical Dictionary for Regulatory Activities (MedDRA), Medical Terminology, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Patient Assessment, Pharmacovigilance, Presentation/Verbal Skills, Problem Solving Skills, Quality Control, Reconciliation, Regulations, Regulatory Reports, Time Management, Writing Skills
LOCATION
Cambridge, MA
POSTED
28 days ago
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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About the Company

T

Tailored Management

CONNECTING TOP TALENT WITH TOP-TIER OPPORTUNITIES

Tailored Management is a global staffing firm that specializes in partnering with large organizations that run their contingent labor program in a VMS/MSP environment. We have the unique capacity to support programs across all scopes and geographic locations from a single headquarters, successfully elevating program performance across the board and minimizing costs, miscommunication and delivery times. But what do we really do? We bring together the best talent with the greatest opportunities.

COMPANY SIZE
1,000 to 1,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1968
WEBSITE
https://www.tailoredmanagement.com/