Do you want to help improve the lives of millions of people?
At FIRE1, we are developing cutting edge technology to reinvent the treatment of heart failure globally. We are growing rapidly and will have opportunities across a wide range of disciplines including engineering, data science, clinical trial specialists, regulatory affairs and many more! If you are interested in joining a dynamic team that is working hard to change the world for the better, we’d love to talk to you. Whatever your role, we offer an opportunity for personal fulfilment and job satisfaction that far exceeds what many employers can offer.
Role: Clinical Site Manager
Location: Remote
Travel: Up to 40%
Description
FIRE1 is seeking a Clinical Site Manager to oversee site management, training, and monitoring activities for our Investigational Device Exemption (IDE) studies. This role ensures that all clinical sites operate in compliance with study protocols, regulatory requirements, and FIRE1 standards, driving the successful execution of our clinical portfolio.
Responsibilities
- Conduct site monitoring visits, including selection, initiation, monitoring and close-out, in accordance with study procedures and regulatory requirements (i.e., Good Clinical Practice, GCP). Document findings and action plans accordingly.
- Facilitate the execution of the Company’s clinical portfolio, including ongoing and new interventional studies, in compliance with international standards.
- Evaluate the quality and integrity of study site conduct to ensure alignment with protocols requirements.
- Proactively identify and implement improvements to enhance overall clinical trial performance
- Build and maintain professional relationships with key physicians, clinical investigators, and consultants to ensure efficient and timely clinical study execution.
- Support sites in tracking and driving subject recruitment
- Ensure accurate documentation of site materials to support the Trial Master File (TMF), verify that the investigator files comply GCP and local regulatory requirements.
- Train and educate medical personnel to FIRE1 specific procedures and equipment.
- Collaborate with FIRE1 departments to develop product-specific training materials for clinical trial teams.
- Provide technical support and troubleshooting to clinical trial.
- Travel up to 40% to support on-site activities as required.
- Apply influencing and consulting skills to guide clinical practices.
- Coordinate with Contract Research Organisations (CROs) and independent contractors to execute the clinical portfolio.
- Manage and track study-related activities in-house and onsite to identify and mitigate potential issues efficiently.
- Engage with the FIRE1 Quality Management System (QMS) to support the overall quality strategy & support the achievement of the business quality objectives.
Qualifications
- Bachelor’s degree in Engineering, Biological Sciences, Nursing, or a related healthcare field.
- Minimum 2 years of experience in a similar role within the medical device industry supporting invasive procedures.
- Strong background in interventional cardiology or related field
- Comfortable in the cath lab or procedural environment; a passion for working in high-impact, fast-paced clinical environments.
- Willing and able to travel frequently (up to 75%)
- Strong attention to detail with excellent analytical and problem-solving skills; able to accurately collect, interpret, and present clinical and technical data.
- Excellent written and verbal communication skills with the ability to interact effectively at all organizational levels.
- Confident communicator and problem solver, able to thrive in dynamic field settings with the ability to interact effectively at all organizational levels.
- Strong organizational and time management skills.
- Solid understanding of implantable devices, medical imaging, cardiovascular anatomy and physiology, and heart failure.
- Proficient in Microsoft Word, Excel, and PowerPoint.
Desirable
- In-depth knowledge of heart failure management, current treatment guidelines, and heart failure related technologies and therapies
- Good working knowledge of FDA and ICH/GCP and European Medical Device regulations and willingness to continuously expand medical, scientific, market, and industry knowledge.
Benefits:
- Medical
- Dental
- 401k
- Vacation/Holidays
Values
WE ARE A TEAM:
- We are a diverse team who respect each other’s opinions. We work and learn together in an open and honest way to achieve our ambitious purpose.
WE CARE ABOUT OUR PATIENTS
- We are determined to give our patients their normal back and strive to continuously improve the patient experience. We appreciate the sacrifice they make to be in our study.
WE ARE PIONEERS
- We embrace the uncertainty of trying something new & appreciate the privilege we have to build a company that will improve millions of lives.
WE ARE AMBITIOUS
- We are purpose driven & will deliver the market leading, self management product for heart failure, to give millions of patients their normal back.
To apply for this role please click below or email your CV to careers@fire1foundry.com