Clinical Trial Safety Specialist

Job Title: Clinical Safety Specialist

Duration: 12 Months (Possible extension)

Location: 100% REMOTE OR HYBRID AT MARLBOROUGH, MA

Hours - 30 to 40 hours per week

Responsibilities:

• Must have clinical safety experience
• Interventional cardiology experience is a plus
• Support the collection, review, reconciliation, and documentation of adverse events (AEs), serious adverse events (SAEs), device deficiencies, and other reportable clinical safety information from clinical studies.
• Perform initial review of clinical safety data for completeness, consistency, and potential safety concerns and facilitate appropriate 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/Medical Affairs personnel to facilitate medical review of adverse events, including assessments of seriousness, relatedness, expectedness, and potential device or procedure relationships, as applicable.
• Support preparation and submission of safety reports and notifications in accordance with applicable regulatory requirements, clinical study plans, and internal procedures.
• Monitor safety data and contribute to the identification, documentation, and escalation of potential safety signals or emerging clinical risks.
• Support periodic and aggregate reviews of clinical safety data, including preparation of safety summaries, trend analyses, listings, and metrics.
• Perform safety data reconciliation across clinical databases, safety systems, complaint systems, and other relevant data sources.
• Collaborate with Clinical Operations, Data Management, Regulatory Affairs, Quality, Medical Affairs, and other functions to resolve safety-data discrepancies and maintain accurate clinical records.
• Support development and maintenance of clinical safety plans, procedures, work instructions, study documents, and other safety-related documentation.
• Provide safety-related input into clinical study documents such as 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, or other independent review committees, when applicable.
• Maintain inspection-ready documentation and support internal audits, regulatory inspections, and responses to safety-related questions.
• Track safety deliverables, timelines, and key performance indicators and proactively identify risks to timely completion.
• Participate in continuous-improvement initiatives designed to improve the quality, consistency, and efficiency of clinical safety processes.
• Maintain current knowledge of relevant medical-device clinical safety regulations, standards, guidance, and internal requirements.

Education/Experience:

• Bachelor’s degree in nursing, life sciences, biomedical sciences, healthcare, engineering, or a related discipline
• 3 years experience within role of safety
• Proven or prior experience with clinical trial safety
• Strong attention to detail with the ability to evaluate complex clinical information and maintain accurate documentation.
• CRO Management experience
• US and international regulations experience as it pertains to conducting pre and post-market clinical studies
• Good Clinical Practice

Preferred:

• Therapeutic knowledge in Interventional Cardiology
• Experience within the medical-device industry
• Knowledge of GCP
• Experience with processing and assessing safety events and medical narrative writing
• Experience with BfArM and EU Regulatory Safety reporting
• Strong clinical database and systems knowledge (preferably Medidata RAVE)