- Develop clinical strategy, create clinical development plans, write clinical protocols, and report results.
- Collaborate with key opinion leaders (KOLs), biostatisticians, and outside consultants to provide clinical science inputs into clinical evidence plans
- Write abstracts, manuscripts, and clinical study reports
- Coordinate review of clinical trial data, including gathering, analyzing, reviewing, and interpreting data; provide preliminary assessments and recommendations
- Identify, set-up and execution of clinical collaborations in Interventional Cardiology and Electrophysiology
- Manage multi-center clinical studies
- Provide support in preparation for scientific meetings (e.g., advisory boards, consultant meetings, and investigator meetings), regulatory submissions, and labelling documents Collaboration contract negotiations and management
- Identify technology trends and collaborate with R&D and clinical development on potential solutions
- Develop clinical claims matrix and validation strategy
- Post market surveillance strategy and execution
- PhD/MS in Health sciences related degree with 3+ years of experience in clinical and/or regulatory affairs or BS/BA with 5 + years related experience, preferably in a highly regulated medical solutions industry
- Extensive knowledge of clinical study design, collaboration management and site monitoring
- Excellent scientific writing skills and interpersonal communication skills
- Demonstrated comprehensive understanding of the medical device development process and testing standards
- Experience of FDA (21 CFR 212, 21 CFR 820 etc.), EU (MDR, MDD, MEDDEV 2.7/1), ISO 14155/GCP and other regulatory standards
- Familiarity with clinical trial design, conduct, and oversight
- Experience with Clinical Claims matrix designs and post market surveillance studies
- Knowledge in writing clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses or literature summaries
- Proven ability to work independently and produce timely quality results on multiple projects with minimal instruction
- Up to 30% travel including international travel
- US Based
- Knowledge of FDA and European regulations to conduct pre-release clinical studies in Interventional Cardiology and Electrophysiology including IDE, PMA, and 510(k)
- Clinical experience in ICE, TEE, TTE, Cardiology, Interventional Cardiology, 3D/4D Echocardiography
- USA based position, remote
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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