WHO ARE WE?
Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs. With our recent PMA approval from the FDA, we are preparing to grow our team – it’s a great time to join Endotronix!
WHAT YOU’LL DO
The Medical Monitor will be responsible for providing medical safety oversight and scientific support to specific clinical programs aligned with the company’s core objectives. This includes direct responsibility for all clinical studies and commercial device use. The Medical Monitor will work closely with the CRO´s Safety/Pharmaco-Vigilance and Data Management teams, with Regulatory Authorities such as the FDA and EU Competent Authorities, providing medical input for filings and safety assessments in collaboration with the Medical Director, Regulatory Affairs and Clinical Operations teams.
Duties and responsibilities:
- Provide medical oversight and input aligned with company’s ‘Patients first’ mission, ensuring patient safety focus across product use aligned with business objectives, good clinical practice, and regulatory requirements, for all ongoing clinical trials.
- Review safety reports: Analyze serious adverse events (SAEs), assess potential device/system related and implant procedure related events for appropriate reporting and action.
- Evaluate patient eligibility: Assess and confirm patient suitability for trial participation, including training of sites on effective screening considerations and implementation of inclusion/exclusion criteria.
- Provide medical guidance: Serve as physician/ medical liaison to clinical trial team, e.g. contact for protocol and medical questions from the internal and/or clinical trial sites, CRO clinical research associates team, offering expert insight on trial-related medical issues.
- Deliver medical training and support: Offer continuous support to ensure compliance with trial protocols and safety guidelines.
- Participate in investigator meetings: Attend, contribute to, and present at investigator meetings, providing medical insights and addressing trial-related concerns
- Ensure adherence to Good Clinical Practices, product safety, standard operating procedures, and to all other quality standards in conducting research
- Performs miscellaneous job-related duties as assigned.
WHAT YOU BRING TO THE TABLE
- Medical Degree required, preferable board certification in internal medicine or cardiology
- Prior experience in medical monitoring within clinical trials is highly valued
- Must be highly motivated, have excellent interpersonal and written communication skills, great desire to help others, composed under stress and well organized
- Broad and deep knowledge of device clinical trial documentation including monitoring requirements, FDA regulations, and operational aspects of clinical trials.
- Must be knowledgeable of FDA and European regulations for risk management and reportability
- Familiarity with clinical research in Cardiology
- Must be highly motivated, have excellent interpersonal and written communication skills, great desire to help others, composed under stress and well organized
- Strong critical thinking and problem- solving skills
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
- Must be highly organized and able to establish priorities
- Outstanding interpersonal and community relations skills and the ability to communicate and work effectively within a diverse community
- Must be willing and able to travel
EDUCATION
- Medical Degree required, board certification in internal medicine or cardiology preferred
- Computer skills - Microsoft Office (Word, Excel, Access, PowerPoint), Internet
WHO YOU ARE
- Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers.
- Someone with a bias for action and quick iteration as opposed to perfection
- A quick learner, who is able to work independently, multitask, and drive your own projects
- An effective communicator and collaborator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights models and tools that provide easily interpretable and actionable results
- A team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the parts
- Passionate about digital healthcare and leveraging Data to deliver innovative solutions at scale
WHAT WE’RE LIKE
- Willing to have the “direct and honest conversation”. Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
- Competitive spirit and drive to win. Strong sense of initiative, internal motivation and an unrelenting focus on results.
- Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
- Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.
- Entrepreneurial, flexible, yet results-focused.
- High degree of intellectual curiosity, honesty and capability.
- Low ego and humble in spirit in spite of his/her track record of outstanding performance.
LIFE AT ENDOTRONIX
Endotronix. is an equal opportunity employer. We are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status or disability.
Furthermore, we do not tolerate any form of discrimination or harassment of our employees by co-workers, supervisors, customers, or vendors. This commitment extends to our policies on recruiting, advertising, hiring, placement, promotion, training, transfer, wages, benefits, termination and all other privileges, terms and conditions of employment.
This policy applies not only to recruitment and hiring practices, but also includes affirmative action in the area of placement, promotion, transfer, rate of pay and termination.
Executive, management and supervisory levels have the responsibility to further the implementation of this policy and ensure conformance by subordinates
