CroíValve are looking for a Senior Field Clinical Specialist to support the clinical program for a cutting-edge structural heart device. The successful candidate will play a critical role in clinical studies including case support, device training, site relationships and ensuring timely data collection for clinical programs.

This position is fully remote and can be based in US or Europe. Majority of case travel will be in US.

Key Responsibilities and Duties

• Provide on-site, real-time guidance during clinical implants and proactively prepare contingency plans to address unforeseen occurrences

• Provide extensive support for patient selection, screening, imaging, etc., to ensure enrolment targets are met

• Coordinate one-on-one training sessions in the hospital environment to educate physicians and site staff on device handling, implantation and troubleshooting techniques related to the equipment required for device implants

• Provide medical staff with clinical instructions to support the full continuum of patient care

• Serve as the designated expert on CroíValve devices by sharing your knowledge and training hospital staff

• Leverage existing relationships with HCPs and KOLSs (e.g., physicians and research coordinators) through regular outreach and education activities, referring HCP visits, product demonstration and conference participation within the structural heart space

• Partner with clinical research colleagues to meet business needs in the field including site qualification and initiation activities, site contracting, data collection, and resolution of critical issues

• Document procedural case observations for regulatory requirements and ongoing continuous improvement

• Recognize restrictions to, protocol adoption, clinical trial awareness, and develop specific strategies with site research team to meet those challenges

• Identify therapy adoption opportunities in collaboration with management team

• Collaborate with product development teams to provide feedback on device features and new device development

• Significant travel >50% of time which will include overnights, largely with US with some International travel

• Ensure interactions with colleagues/stakeholders fully reflects the company values:

o One Team: working together to ensure the whole is greater than the sum of the parts

o Personal Ownership: deliver on commitments

o Open Communication: Honest open-minded communication

o Fun: celebrate the successes

o Continuous Learning: at an individual and company level

o Solution Orientated: Identify problems but focus your energy on solutions

o Quality Focused: patient safety comes first

Education and Experience

• A minimum of 5 years of relevant industry or clinical experience

• Experienced in case support of structural heart devices in a cath lab setting

• Cardiac echo imaging skills required, ideally including the tricuspid valve, including the ability to proctor a case from an echo navigation and image acquisition perspective

• Experience with CT imaging is preferred

• Experience with clinical studies, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials

• Experience with delivering device training

• Strong knowledge of cardiovascular science and valvular heart disease processes

• Formal education and clinical experience in one or more of the following specialties is preferred: Nursing (RN/BSN/MSN), Physician Assistant (PA-C), CV Sonography (RDCS/RDS), Cardiovascular Technician (RCIS/CVT/RTR); alternatively, a background in R&D product development prior to moving to a field clinical role

• Excellent communication, organisational and time management skills

• Excellent influencing and negotiation skills

The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned from time to time.

To apply please email your CV with a cover letter to info@croivalve.com