What are the responsibilities and job description for the Clinical Trial Consultant position at Tailored Management?
Job Title: Clinical Trial Consultant II
Location: 140 6th Street, Cambridge, MA 02142
Work Schedule: 40 hours per week | Cambridge office – 2 days onsite
Duration: 12-month contract (with potential for extension or conversion)
Pay Rate: $50.00 – $60.22/hour (W2)
Benefits: Weekly pay, Medical, Dental, and Vision coverage
Job Overview
The Clinical Trial Consultant II is responsible for case processing and quality control (QC) of clinical trial Individual Case Safety Reports (ICSRs), as well as post-marketing safety cases, including those originating from sanctioned countries.
Key Responsibilities
- Perform triage, intake, case entry, and quality control of ICSRs from Client-sponsored studies and other assigned cases
- Develop clear safety narratives, perform MedDRA coding, and draft follow-up queries and event notifications for internal stakeholders
- Conduct retrospective quality reviews of processed cases to ensure compliance and accuracy
- Independently manage assigned case workload, including weekends and holidays, to ensure timely case completion and on-time regulatory submissions
- Review and resolve reconciliation issues between clinical and safety databases in collaboration with Data Management teams
- Provide investigation details and documentation related to late regulatory reporting of clinical trial cases
Required Skills and Qualifications
- Strong knowledge of global and local pharmacovigilance and safety regulations
- Excellent written and verbal communication skills
- Hands-on experience with safety database systems such as ArisG, Argus, and Veeva
- Solid understanding of global safety reporting regulations and guidelines, including FDA, ICH, and EU pharmacovigilance requirements
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook)
- Strong understanding of medical and clinical practices, medical concepts, and terminology
Education & Experience
- Education: Bachelor’s degree in science or a healthcare-related field
- Experience: Minimum of 4 years of pharmacovigilance experience
Salary : $50 - $60