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Job Title: Senior Manager, Clinical Safety

Role Level: Individual Contributor/People Manager

Supervisor/Manager Title: VP, Clinical Affairs 

Job Location & Environment: Remote

Job Description Summary: The Senior Manager, Clinical Safety ensures clinical safety data review and evaluation in accordance with pre-market and post-market regulatory requirements. Communicates potential and known risks to Management, Quality Assurance, Regulatory Affairs, and Clinical Affairs personnel. Conducts clinical trial safety and commercial safety activities.

Job Responsibilities: 

• Provides clinical safety expertise to the Quality Assurance, Regulatory Affairs, and Clinical Affairs teams and programs.
• Tracks adverse events (AEs) cross all active trials and provide safety review of AEs and completes appropriate documentation needed for adjudication.
• Participates in protocol review for safety input such as requirement of a CEC or DSMB, adverse event reporting requirements and endpoint determination.
• Supports CEC / DSMB adjudication process including source documents and narratives review and handling
• Participates in the formulation of case report forms, specifically with regards to reporting and management of adverse events.
• Assists with all activities related to establishing and managing all safety-related processes.
• Oversee preparation of periodic safety reports to the FDA and IRB/IECs.
• Oversee preparation of safety section of clinical study reports, clinical expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal regulatory filing
• Manages vendors responsible for safety services including Safety Management, Clinical Events Committee, Data Monitoring Committee, Imaging Service, etc.
• Provides device safety input for JenaValve clinical trials documents and training materials.
• Collaborates with cross-functional teams on activities related to managing the safety review and its appropriate documentation.
• Presents post-market and clinical safety and risk management evaluations as necessary to the company management team.
• Participates in pre-market and post-market clinical safety and risk management programs.
• Provides input and review for building safety CRFs and clinical documents as appropriate to ensure company processes meet regulatory and scientific quality.
• Supports operational tasks in Clinical Affairs department.
• Mentors and develop junior team members.

Required Education and Experience: 

• Bachelor’s degree or equivalent combination of education and experience. Masters, MD, PhD, Nurse Practitioner or Physician Assistant degree (or the equivalent work experience) preferred. 
• Must have a strong clinical orientation and knowledge of diverse categories.
• Cardiovascular / structural heart therapeutic area experience is highly desired.
• 5+ years of experience in clinical safety, clinical research, and vigilance.
• Demonstrated in-depth knowledge of principles of clinical trial methodology and design, safety monitoring of trials, assessment of medical device risks and benefits, and safety assessment of medical devices both on the market and in development and global safety regulations.

Skills and Abilities Required for This Job:

• Ability to critically evaluate safety data from multiple sources (clinical trial data, academic sources, literature, etc.) and present the findings clearly in both written and oral communications.
• Experience and knowledge of FDA, ICH, GCP, AE reporting and overall conduct of clinical trials.
• Able to plan work to meet deadlines and effectively handle multiple high-volume priorities.
• Experience using database (EDC) applications for clinical trial management and safety management.
• Experience in participating in safety review processes.
• Familiar with medical terminology and MedDRA.
• Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable.
• Working knowledge of the use of Microsoft suite of software products including Excel and Word. Proficiency in PowerPoint is desired.

Physical Requirements: 

• Standard office environment requirements.
• Minimal travel up to 10%.