Clinical Trial Consultant II
Hydrogen Group ·www.hydrogengroup.com
Apply directClinical 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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Frequently asked questions
Who is hiring for the Clinical Trial Consultant II role?
Hydrogen Group is hiring for the Clinical Trial Consultant II position, a Shazamme client. Apply directly on the employer's career site.
Where is the Clinical Trial Consultant II job located?
The Clinical Trial Consultant II role with Hydrogen Group is based in Cambridge, MA, US.
What does the Clinical Trial Consultant II role pay?
Hydrogen Group lists the Clinical Trial Consultant II role at USD 55–60 per hour.
Is the Clinical Trial Consultant II role full-time or contract?
This is a full time position at Hydrogen Group.
What experience level is the Clinical Trial Consultant II role?
The Clinical Trial Consultant II position is aimed at mid-level candidates.
How do I apply for the Clinical Trial Consultant II role at Hydrogen Group?
Apply directly on Hydrogen Group's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.