Overview
$100,000.00 - $100,000.00 Salary
Position Type: Full Time
Education Level: 4 Year Degree
Description
Job Title: Specialist, Clinical Safety
Role Level: Individual Contributor (IC)
Supervisor/Manager Title: Senior Manager, Clinical Safety
Job Location & Environment: Irvine, CA – Corporate Office
Job Description Summary: Reporting to the Senior Manager, Clinical Safety, the Specialist, Clinical Safety supports the conduct and timely execution of JenaValve clinical trials by monitoring subject safety, ensuring accurate and compliant adverse event data reporting in clinical databases, and contributing to the review and analysis of clinical safety data. The role collaborates closely with cross-functional teams including Project Management, Field Monitoring, Regulatory Affairs, and the Case Review Board to maintain the quality and integrity of safety data collected across all active trials, including the ALIGN-AR Pivotal Trial, JENA-VAD Registry, ALIGN-AR EFS Trial, and the ARTIST Trial.
Job Responsibilities:
- Conduct assessments of adverse events (AEs) and complaints across multiple clinical studies, including UADE (Unanticipated Adverse Device Effect) 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.
- Complete training for internal SOPs and maintain current knowledge required for the role.
Qualifications
Required Education and Experience:
- 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.
Skills and Abilities Required for This Job:
- Clinical knowledge in cardiology; structural heart disease or transcatheter valve therapy experience preferred.
- Knowledge of GCPs governing clinical trial conduct; working knowledge of medical device regulations and ICH guidelines.
- Experience working across all phases of clinical study conduct from a clinical safety perspective.
- Familiarity with MedDRA coding, adverse event terminology, and safety database management.
- Experience with EDC (Electronic Data Capture) platforms for clinical trial management and safety reporting.
- Basic understanding of clinical trial design and statistical concepts as applied to safety evaluation.
- Ability to work collaboratively as part of a multi-functional medical device development team.
- Excellent oral and written communication skills; strong interpersonal skills and ability to work effectively cross-functionally and cross-culturally.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Physical Requirements:
- Standard office environment requirements.
- Minimal travel, up to 10%.
