Job Description
Job Description
POSITION PURPOSE
The Clinical Specialist plays a pivotal role in supporting Berlin Heart’s medical devices in a dynamic clinical environment, as well as in the research and development space. This role requires strong mastery of cardiovascular physiology and medical device technology, paired with the ability to translate complex concepts into effective clinical support. This high-visibility position directly impacts the company's success by providing clinical support, conducting studies, and ensuring compliance with all regulatory and Good Clinical Practice (GCP). The clinical specialist serves as the primary interface between Berlin Heart Inc. and its customers regarding clinical use of all products and devices.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
The duties of Clinical Specialist are to include but not limited to:
- Provide on-site clinical support before, during, and after implant procedures at centers across North and South America significant overnight travel required).
- Conduct patient follow-ups and collect data on outcomes, adverse events, and related patient issues.
- Establish and maintain strong clinical and business relationships with hospital staff at all levels.
- Assist in sales and marketing activities as assigned.
- Provide 24/7 emergency telephone support on a rotational basis.
- Contribute to the development of educational materials and scientific publications.
- Communicate actively with clinical team members and participate in team meetings and updates.
- Attend Clinical VAD-related meetings and contribute to discussions.
- Develop and implement Standard Operating Procedures (SOPs) as needed.
- Engage in continuing education to stay current with clinical advancements.
- Assess and address the clinical needs of customers.
- Demonstrate in-dept understanding of device technology, system components, and physiological interactions to support safe and effective clinical use.
QUALIFICATIONS
EDUCATION:
- Bachelor’s degree with allied healthcare, biomedical engineering, or related scientific discipline (Graduate degree preferred).
- Background in Nursing, Perfusion, Cardiology, or Biomedical Engineering with relevant clinical exposure (Pediatric emphasis preferred).
REQUIRED KNOWLEDGE:
- Strong understanding of clinical affairs documentation, study design, and implementation.
- Demonstrated leadership and communication skills (both written and spoken).
- Knowledge of ventricular assist devices (VADs) preferred.
- Strong foundational knowledge of cardiovascular physiology and medical device systems, with the ability to apply this knowledge in a clinical setting.
EXPERIENCE:
- Minimum 3-5 years of experience in cardiology/cardiac surgery clinical patient management, medical device clinical support, medical device clinical trials, and/or regulatory affairs.
- Experience supporting cardiovascular medical devices in a clinical environment is strongly preferred.
- Registered Nurse (RN) or Certified Clinical Perfusionist (CCP) preferred.
Company DescriptionBerlin Heart develops, manufactures, and markets innovative ventricular assist devices (VADs) for mechanical circulatory support. The Berlin Heart portfolio of ventricular assist devices offers you the ability to treat your patients with uni- or biventricular support as bridge to recovery and bridge to transplantation. EXCOR Pediatric is clinically reliable for support times of a few days up to several years as well as supports pediatric patients of all ages, from newborns to adolescents, with outstanding clinical performance proven in over 2,300 pediatric patients worldwide.
Company Description
Berlin Heart develops, manufactures, and markets innovative ventricular assist devices (VADs) for mechanical circulatory support. The Berlin Heart portfolio of ventricular assist devices offers you the ability to treat your patients with uni- or biventricular support as bridge to recovery and bridge to transplantation. EXCOR Pediatric is clinically reliable for support times of a few days up to several years as well as supports pediatric patients of all ages, from newborns to adolescents, with outstanding clinical performance proven in over 2,300 pediatric patients worldwide.