Specialist, Clinical Safety

Job Responsibilities

• Conduct assessments of adverse events (AEs) and complaints across multiple clinical studies, including UADE determinations; perform complaint handling assessments and report AEs per regulatory requirements, trial safety processes, and JenaValve procedures.
• Review and analyze aggregate safety reports to identify early safety signals; escalate findings to leadership with recommended next steps.
• Track timeliness of AE and SAE reporting by investigational sites and follow up as needed to ensure compliance with protocol-specified timelines.
• Interact with investigational sites and field monitors to obtain additional pertinent information on Case Report Forms and medical documentation (source documents).
• Manage, prepare, and review event narratives for internal review or external reviews (e.g., Clinical Events Committee, Data Safety Monitoring Board) and for regulatory submissions.
• Provide support to the MedDRA coding team on complex coding questions; participate in MedDRA coding team meetings and advise on important medical concepts.
• Provide clinical and medical subject matter expertise to address safety-related questions from internal study teams, field support personnel, monitors, and study sites during the conduct of studies.
• Contribute to clinical aspects of protocol development; specifically develop the Safety section of clinical trial protocols including adverse event definitions, AE reporting requirements, and risk sections.
• Collaborate with data management and cross-functional teams on the development of case report forms, study-specific safety reports, and other study forms, ensuring alignment with clinical definitions and EDC data flows.
• Support DSMB and CEC startup and management activities including vendor selection and approval, member selection, charter development, and ongoing conduct during clinical trials.
• Lead site CRF development for AE Main Forms and AE Sub-forms; review edit checks and provide input into other CRF form development as needed.
• Support PMA/APR activities including query closure, case narratives, and accurate presentation of endpoint-related data.
• Assist the Clinical Safety team in daily safety reviews, data reconciliation, periodic reporting, and identification of necessary source documents.
• Contribute to other clinical and medical affairs activities as needed and support continuous process improvement.

Qualifications

• 2+ years of experience in clinical trial research required; medical device experience strongly preferred.
• Bachelor's degree or higher in a life sciences, health sciences, or related field required; advanced clinical degree (NP, PA, MD, or international equivalent) highly preferred.
• Working knowledge of HIPAA, ICH, GCP, and regulatory requirements related to clinical research.
• Experience with cardiovascular or structural heart therapeutic areas is a significant advantage.
• Strong organizational skills and time management abilities in a dynamic, fast-paced environment; ability to manage multiple concurrent priorities.
• Excellent critical thinking skills and strong written and verbal communication skills.
• Self-motivated, detail-oriented, and able to work independently as well as part of a collaborative team.