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Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.

To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.

Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.

About the role:

The Project Manager will identify, improve, and implement key business processes which define how we as a business operate, and which shape company culture. The ideal candidate should be mission-driven and eager to learn and kickstart their career in a fast-growing medical device startup. This role has high visibility to all levels within the organization, reports to the Director of Marketing and Business Operations. and will also work closely with the executive team. This is a unique opportunity to gain exposure to multiple business areas, and serve as the point person for key initiatives that the drive the business and promote employee engagement.

What you’ll be doing:

• Overseeing and supporting process improvement for day-to-day business operations
• Establishing processes that promote company efficiency, support company culture and values
• Ensuring compliance to company, federal, and local business requirements
• Developing internal infrastructure systems for long-term sustainability
• Leading build-out of administrative systems (e.g., finance, HR, legal, reporting)
• Supporting company culture and employee experience
• Maintaining contracts with various partners and suppliers
• Developing and manage inventory system for company equipment
• Creating reporting materials and presentations for a variety of stakeholders including company leadership and investors
• Supporting activities related to conferences and trade shows
• Supporting corporate marketing and communications activities

• Ideally, we are seeking 3 years’ experience in an operational or financial role, preferably at a high-growth startup engaged in life sciences or another regulated environment such as financial services, and/or experience in a consulting firm assigned to entrepreneurial clients
• Alacrity to learn, solve problems, take ownership, and build their career within a high-growth startup
• Mission-driven and excited about the impact new technologies could have on our health
• Comfortable with change and thrive in the environment it creates
• Strong business judgement and proven ability to perform analysis, draw key insights, and form and execute a strategy
• Excellent communication and organizational skills and experience leading engagements with external stakeholders
• Self-starter who is able to own complex projects with minimal input, break them into smaller components, and relentlessly drive towards execution
• Highly analytical, with advanced Excel and PowerPoint skills preferred
• Experience building and leading people operations infrastructure preferred

• Candidates located in or willing to relocate to the Chicago, IL area (hybrid).
• This position may require 10-20% travel depending on candidate’s location.

We are looking for individuals to join the Cardiosense team who share our values and are passionate about advancing health outcomes for patients!

Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.

To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.

Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.

ABOUT THE ROLE:

The Clinical Operations Associate (COA) is responsible for assigned aspects of clinical study support including, but not limited to, monitoring and site management in accordance with applicable Standard Operating Procedures (SOPs) and the International Conference on Harmonisation’s (ICH) guidelines for Good Clinical Practice (GCP). The COA is responsible for study site management and relationships to assure and assess that sites conduct the study protocol consistent with regulatory compliance, data reliability, and the proper care and treatment of study participants. Additionally, they will be a resource to the clinical site for study support, study training, and liaise with the sponsor team to assure smooth study and successful trial execution. The Clinical Operations Associate represents the organization in a professional and collegial manner and reports to the Director of Clinical Operations. 

WHAT YOU'LL BE DOING:

• Provide study support including training, re-training, or acts as a general resources to assure smooth trial execution
• Recognize sites for enrollment success and supports and troubles-shoots solutions with sites when enrollment is not meeting anticipated targets
• Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials
• Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification, as required
• Ensure the integrity of data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and internal SOPs
• Participate in audit preparation and follow-up activities, as needed
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations
• Verify proper management and accountability of Investigational Product
• Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate
• Manage essential documents as required by local regulations and ICH GCP before, during, and after a clinical study; assist with resolution of investigational site/data queries 
• Submit protocols and supporting documents to internal and external regulatory bodies (i.e., Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies and/or study amendments.
• Manage and maintain electronic regulatory files (e.g., staff resumes, licenses, training certificates, equipment receipts, investigation logs). Reviews documentation as needed to support regulatory filings and maintains research files and documentation required by regulations.

• General knowledge of regulatory requirements & GCP
• Ability to multi-task and deal with shifting priorities
• High proficiency with full Microsoft applications
• Strong spoken and written communication skills; fluency in English
• Strong interpersonal, collaborative, and time management abilities
• Excellent organizational skills; accurate and detail-oriented

• Bachelor’s degree in a life science-related field
• 2 years’ experience in a clinical trials research environment required
• Experience with clinical study regulatory document management
• Experience with executing clinical studies/trials
• Experience with wearable/device studies is highly preferred
• Experience working in cardiovascular trials is preferred
• Valid driver’s license required

This role requires travel to clinical trial sites, ranging from 25-30%.

Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.

To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.

Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.

What you'll be doing:

As R&D Director for Clinical AI, you will play a cross-functional, leadership role across both our data science and clinical teams driving ideation, implementation, validation, and commercialization of our noninvasive hemodynamic algorithms.

In this role, you will:

• Own clinical algorithm design, development, and validation strategy.
• Collaborate with clinical and regulatory stakeholders to define requirements for data science team and develop "KPIs" to evaluate model training.
• Design end-to-end study infrastructure and data pipelines to streamline collection of multiple unstructured data streams.
• Author scientific and medical manuscripts for publication in journals and presentation at conferences.
• Prepare and present statistical analysis of algorithm performance to scientific advisory board.
• Drive productization and commercialization strategy for AI products. Plan and lead interactions with the FDA and other regulatory agencies.
• Negotiate data usage agreements with research institutions and clinical sites. Partner with legal counsel to develop IP strategy for AI product portfolio.
• Participate and engage in thought leadership working groups around the regulation of AI in clinical practice

• Deep understanding of medical, scientific, or clinical research techniques and principles. Ph.D. or comparable experience in Engineering, Computer Science, Statistics, Mathematics, Bioinformatics or similar fields
• Experience in full-cycle development of clinical algorithms from model training through regulatory clearance
• Able to rapidly acquire familiarity with emerging technologies and software algorithms.
• Excellent ability to communicate complex and machine learning concepts to non-technical stakeholders.
• Experience working with cardiology departments and cath labs preferred.
• Experience with modern machine learning frameworks such as TensorFlow or PyTorch preferred. Startup experience preferred.

Location and Travel:

Candidates located in or willing to relocate to the Chicago, IL area are preferred, however other locations will also be considered. This position may require 25% travel depending on candidate’s location.

Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.

To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.

Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.

About this role:

The Senior Signal Processing Engineer is responsible for developing novel algorithms to be used in a physiological waveform data solution that will leverage data from multi-model sensors to detect early onsets of cardiac diseases. They will work across clinical and engineering teams to support data collection and to build and optimize end-to-end solutions. A face-paced environment at Cardiosense will provide opportunities for growth in technical understanding, effective leadership, and project development.

What you'll be doing:

• Help develop software solutions that provide clinically relevant metrics and indications from unobtrusive and non-invasive sensors. 
• Apply digital signal processing techniques to physiological waveforms (PPG, ECG, SCG, etc.) and build novel machine learning algorithms for hemodynamic assessment. 
• Build and prototype analysis pipelines. Optimize database and computational resources for the data science team. 
• Collaborate across hardware and software engineering teams to identify opportunities for design improvements and operational efficiency. 
• Work closely with the clinical research team to design end-to-end study infrastructure and pipeline to collect data from clinical sites.

• MS/PhD in Electrical Engineering, Statistics, Bioinformatics, Computational Biology, Computer science, Mathematics, or equivalent practical experience
• 2 years of experience in data analysis or related fields such as Data Scientist, Computational Biologist, or bioinformatics 
• Experience with wearable health sensors and related biometric algorithms (e.g. PPG, ECG, respiratory signals)
• Expertise in digital signal processing techniques including noise reduction, frequency domain analysis, and filtering techniques.
• Deep understanding of both classical machine learning and AI/deep learning concepts
• Ability to effectively communicate requirements, manage tasks, and relay results to management teams.
• Experience with analytic database design and application
• Understanding of good machine learning practice for medical device development 

Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.