Description: Title: Clinical Specialist II Location: Hybrid (MA) or Remote Duration: 12 Months (Possible Extension) *Must have clinical safety experience *Interventional cardiology experience is a plus Job Description: Please provide specific list of the Duties and Tasks your worker will be expected to perform on a daily/regular basis: •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/Skills required to successfully perform the above duties/tasks: •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. •Strong organizational and prioritization skills with the ability to manage multiple activities and deadlines. •Effective written and verbal communication skills. •Demonstrated ability to collaborate effectively within cross-functional teams. •CRO Management experience •US and international regulations experience as it pertains to conducting pre and post-market clinical studies •Good Clinical Practice Preferred qualifications: ⦁ Fluent in English ⦁ 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