Clinical Safety Specialist – Medical Device Clinical Trials

Clinical Safety Specialist – Clinical Trials

Location: Hybrid in Massachusetts or Remote

Employment Type: Year Long Contract with opportunity to extend

Schedule: 30–40 hours per week

Pay: $40 an hour or about $81,500 a week.

Work Authorization: Applicants must be authorized to work in the United States without visa sponsorship now or in the future. The client cannot consider candidates who require sponsorship.

Position Summary

We are seeking a Clinical Safety Specialist to support clinical trial safety activities, including the collection, review, reconciliation, documentation, and reporting of clinical safety information. This individual will collaborate with study teams, clinical sites, medical reviewers, and cross-functional partners to maintain accurate safety records, facilitate timely event review, and support compliance with applicable regulatory requirements.

Clinical safety and clinical trial safety experience are required. Experience in interventional cardiology and the medical-device industry is preferred.

Key Responsibilities

Clinical Safety Event Management

• Support the collection, review, reconciliation, and documentation of adverse events (AEs), serious adverse events (SAEs), device deficiencies, and other reportable safety information from clinical studies.
• Review clinical safety data for completeness, consistency, and potential safety concerns; coordinate follow-up with study teams and clinical sites.
• Coordinate safety-event workflows to support timely medical assessment, event classification, reporting, and closure.
• Partner with Medical Safety and Medical Affairs personnel to facilitate assessments of event seriousness, relatedness, expectedness, and potential relationships to study devices or procedures, as applicable.
• Support the preparation and submission of safety reports and notifications in accordance with applicable regulatory requirements, clinical study plans, and internal procedures.

Safety Data Review and Reconciliation

• Monitor safety data and contribute to the identification, documentation, and escalation of potential safety signals or emerging clinical risks.
• Support periodic and aggregate safety reviews, including preparation of safety summaries, trend analyses, data listings, and metrics.
• Reconcile safety data across clinical databases, safety systems, complaint systems, and other relevant sources.
• Collaborate with Clinical Operations, Data Management, Regulatory Affairs, Quality, and Medical Affairs to resolve discrepancies and maintain accurate clinical records.

Study Documentation and Compliance

• Support the development and maintenance of clinical safety plans, procedures, work instructions, and study-specific safety documentation.
• Provide safety-related input into protocols, case report forms, informed consent materials, clinical reports, and risk-management documentation, as appropriate.
• Support safety activities associated with Data Monitoring Committees, Clinical Events Committees, and other independent review committees, when applicable.
• Maintain inspection-ready documentation and support internal audits, regulatory inspections, and responses to safety-related inquiries.
• Maintain current knowledge of applicable medical-device clinical safety regulations, standards, guidance, and internal requirements.

Cross-Functional Coordination and Process Improvement

• Support coordination and oversight of contract research organization (CRO) safety activities and deliverables.
• Track safety deliverables, timelines, and key performance indicators; proactively identify and escalate risks to timely completion.
• Participate in continuous-improvement initiatives to strengthen the quality, consistency, and efficiency of clinical safety processes.

Required Qualifications

• Bachelor’s degree in nursing, life sciences, biomedical sciences, healthcare, engineering, or a related discipline.
• At least 3 years of safety-related experience, including direct experience supporting clinical trial safety activities.
• Experience managing or overseeing CRO activities.
• Experience applying U.S. and international regulatory requirements to pre-market and post-market clinical studies.
• Working knowledge of Good Clinical Practice (GCP).
• Strong attention to detail and the ability to evaluate complex clinical information and maintain accurate documentation.
• Strong organizational and prioritization skills, with the ability to manage multiple activities and deadlines.
• Effective written and verbal communication skills.
• Demonstrated ability to collaborate across functions and work independently.

Preferred Qualifications

• Experience in the medical-device industry.
• Therapeutic knowledge or clinical experience in interventional cardiology.
• Experience processing and assessing safety events and writing medical narratives.
• Experience with German Federal Institute for Drugs and Medical Devices (BfArM) and European Union regulatory safety reporting.
• Strong clinical database and safety systems knowledge, preferably including Medidata Rave.
• Fluency in English.