TalentBurst, an Inc 5000 company · 22 hours ago
Clinical Trial Consultant II
Cambridge, MA
Contract
Hybrid
Mid Level
$55/hr - $60/hr
4+ years expTalentBurst, an Inc 5000 company, is seeking a Clinical Trial Consultant II. The role is responsible for case processing and quality control of clinical trial ICSRs and postmarket case processing from sanctioned countries.
RecruitingStaffing Agency
Hiring Manager
Himani B.
Responsibilities
Triage, Intake, case entry and QC of ICSRs originating from sponsored studies or other assigned cases
Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
Perform retrospective quality checks on processed cases
Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
Provide investigation details into late regulatory reporting of CT cases
Qualification
Required
Knowledge of Global and local safety regulations
Excellent written and verbal communication skills
Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
Education: Bachelor's degree in science or healthcare related field
Experience: 4+ years experience in pharmacovigilance
Company
TalentBurst, an Inc 5000 company
Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Jamie Jacobs (she/her)
Sr Vice President of Strategic Partnerships and DE&I/ESG Council
Recent News
2025-11-19
Seattle TechFlash
2025-04-17
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