Clinical Trial Consultant II
Posted Today by Hydrogen Group
Negotiable
Undetermined
Hybrid
Cambridge, Massachusetts
Summary: The Clinical Trial Consultant II role is focused on supporting case processing and quality control of clinical trial ICSRs and postmarket case processing for a leading global biopharmaceutical company. The position requires a detail-oriented individual to manage assigned cases, ensuring timely delivery and compliance with regulatory reporting. The consultant will also perform narrative writing, coding, and quality checks on processed cases. This is a 12-month contract position based in Cambridge, MA, with a hybrid working arrangement.
Key Responsibilities:
- Triage, intake, case entry, and QC of ICSRs originating from client-sponsored studies or other assigned cases
- Perform 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 in collaboration with Data Management
- Provide investigation details into late regulatory reporting of CT cases
Key Skills:
- Bachelor's degree in a science or healthcare-related field
- 4+ years of experience in pharmacovigilance
- 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 FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
- Strong computer skills within the Microsoft Office suite (Word, Excel, PowerPoint, and Outlook)
- Knowledge of medical and clinical practices with a strong understanding of medical concepts and terminology
Salary (Rate): £55 hourly
City: Cambridge
Country: United States
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Clinical Trial Consultant II
Cambridge, MA – 2 Days Onsite
Schedule:
Standard EST Hours
Duration:
12-Month Contract
Pay:$55-60/hr (W2)
Our client is a leading global biopharmaceutical company focused on the research, development, and delivery of therapies for neurological and rare diseases. They are seeking a detail-oriented Clinical Trial Consultant II to support case processing and quality control of clinical trial ICSRs and postmarket case processing from sanctioned countries.
Essential Functions and Responsibilities
- Triage, intake, case entry, and QC of ICSRs originating from client-sponsored studies or other assigned cases
- Perform 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 in collaboration with Data Management
- Provide investigation details into late regulatory reporting of CT cases
Education and Experience
- Bachelor's degree in a science or healthcare-related field
- 4+ years of experience in pharmacovigilance
Knowledge and Skills
- 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 FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
- Strong computer skills within the Microsoft Office suite (Word, Excel, PowerPoint, and Outlook)
- Knowledge of medical and clinical practices with a strong understanding of medical concepts and terminology
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