About the job
Join us today and take life to heart!
Corcym is a global medical device company focused on the structural heart area. Our vision is to become the leading company dedicated to Heart Surgeons and their Patients by providing the best solutions to fight structural heart disease. We aim to help Heart Surgeons treat Patients better today and in the future.
We offer a complete portfolio of surgical solutions with a heritage spanning more than 50 years, leveraging on a complete and distinctive set of technologies, capabilities and infrastructure.
We employ approximately 850 people in over 100 countries, ensuring a strong presence to continuously support Patients, Healthcare Professionals, and healthcare systems worldwide.
You can learn more about us at our webpage: Corcym
Clinical Specialist
The Clinical Specialist provides clinical/technical product support and training aligned with specific country and regional team goals. The incumbent of this position mainly supports western regions of USA and is flexible to support central and eastern USA regions as needed.
It is preferred for successful candidates to reside in western regions of USA.
Key Responsibilities
- Provide preoperative, intraoperative, and postoperative product support both in person and remotely, as well as facilitate cases in the OR with a remote Proctor.
- Provide and facilitate field-based product training activities using both the “Dry Lab” chest demo models and the Pig Heart Labs (Wet Labs) for all CORCYM products, specializing in Perceval, Memo, and HAART.
- Effectively disseminate information regarding approved labelled indications for use.
- Effectively disseminate field-based/product information for commercial functions/ Trade Shows to enhance strategy development.
- Consult with Global Medical Affairs as needed for additional support for scientific and medical inquiries.
- Provide competent and confident intraoperative case coverage for all CORCYM technologies.
- Provide product training regarding approved labelled information including intended use, indications for use, and target populations.
- Build relationships with leading experts in clinical practice or research relevant to the products in the company portfolio.
- Develop a personal knowledge base to be able to respond with credibility and expertise to answer inquiries regarding all CORCYM technologies.
- Lead and participate in information dissemination and training activities for: internal audiences (journal clubs, new hire training, refresher courses) and external audiences (webinars, symposia, medical society meeting activities).
- Provide assistance to Global Medical Affairs in refining educational/training/research programs and Sales/Marketing in refining marketing/educational materials.
- Transmit inquiries to global Medical Affairs regarding off-label use, investigator-initiated research proposals, Medical Information Requests (MIR).
- Work as a liaison between distributor/customer and commercial quality.
- Must become Certified as/in all the following within 12months of employment: Perceval Clinical Trainer, and CT reading service.
- Must be Certified as/in all the following within 18 months of employment: HAART Clinical Trainer.
- Perform Demo labs (dry and wet) in the field whether at Hospitals, Physician offices, or at Industry conferences.
Knowledge, Skills, And Abilities
- Must have scientific expertise in the relevant therapeutic area.
- Strong technical and presentation skills.
- Networking skills and the confidence to interact with senior experts on a peer-to-peer level.
- Willingness to keep up to date with scientific literature.
- Willingness to travel extensively and to be away from home, when required.
- Strong written and verbal communication skills.
- Strong work ethic and ability to multi-task and work independently.
- Able to collaborate in team environment.
- Have in-depth and up-to-date personal knowledge base regarding all CORCYM products.
Education And Experience
- Undergraduate degree preferably in biomedical sciences (RN, PA, RT(R), RDMS, Biomedical Engineer).
- Minimum 3-5 years of clinical experience in a related medical field
Working Conditions
- Ability to travel minimum 80% across USA.
What We Offer
- Health, Vision, & Dental.
- Life & Disability.
- Employee Assistance Program.
- 401K, ROTH, Employer matching.
- Base compensation plus bonus.
Compensation
- Base annual compensation range is $100,000-120,000 USD.
Successful candidate final compensation is determined by multiple factors including, but not limited to: relevant experience & education, regions, applicable knowledge and skills.
Apply Instructions
Please visit: https://corcym.breezy.hr/ to apply
About the job
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
As the Clinical Research Specialist, you will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
How you will make an impact:
- Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities
- Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
- Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
- Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
- Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
- Other incidental duties
What you’ll need (Required):
- Bachelor’s Degree or Equivalent in Life Sciences or Nursing
- 3 years of work experience in clinical research (site management, clinical project management, field monitoring, and/or clinical research coordination) including quality assurance/control and regulatory compliance or field monitoring with experience in the healthcare industry
- Experience in electronic data capture
- Covid vaccination
- Ability to travel up 25%
What else we look for (Preferred):
- Knowledge of cardiovascular physiology and structural heart anatomy
- Previous medical device Clinical Research experience in cardiology
- Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification)
- Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k)
- Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
- Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills are required
- Strong problem-solving and critical thinking skills
- Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
- Moderate understanding of regulatory submissions, reporting, and audits
- Ability to manage confidential information with discretion
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
- Ability to build productive internal/external working relationships
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For Illinois (IL), the base pay range for this position is $85,000 to $115,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.