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Clinical Affairs Manager- Cardiology

Job Description

Clinical Affairs Manager – Cardiology

Position Overview-
The Clinical Affairs Manager for Cardiology is responsible for developing and implementing clinical strategies, designing, and executing clinical studies for a portfolio of cardiology products. This position will drive clinical evidence generation in Interventional Cardiology, Electrophysiology, and Intracardiac Echocardiography (ICE), engage with key opinion leaders and clinical researchers to identify and conduct clinical studies to drive adoption of our interventional ultrasound portfolio through single and multi-center clinical studies. In collaboration with medical affairs and clinical development you will be responsible to define clinical study protocols and support our customers with clinical research, publications, and peer-reviewed articles.

Responsibilities:
  • 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
 Required Knowledge/Skills, Education, and Experience: 
  • 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
 Preferred Knowledge/Skills, Education, and Experience: 
  • 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
*LI-WC1

Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Experienced Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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