Tailored Management · 10 hours ago
Clinical Trial Consultant
Cambridge, MA
Contract
Hybrid
Mid Level
$50/hr - $60.22/hr
4+ years expTailored Management is seeking a Clinical Trial Consultant II responsible for case processing and quality control of clinical trial Individual Case Safety Reports (ICSRs). The role involves managing case workload, ensuring compliance and accuracy, and collaborating with Data Management teams.
ConsultingHuman ResourcesInformation Technology
Hiring Manager
Anjaneyulu Kukkala
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
Qualification
Required
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: Bachelor's degree in science or a healthcare-related field
Experience: Minimum of 4+ years of pharmacovigilance experience
Benefits
Weekly pay
Medical
Dental
Vision coverage
Company
Tailored Management
Tailored Management is a staffing and recruiting company that offers information technology staffing and recruitment services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Jeff Anderson
Managing Partner & Client Relations Executive
Savannah Deskins
Manager, Administration & Office of the CEO
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