Clinical Program Manager

Who We Are

Tesseract’s mission is to democratize healthcare delivery to everyone on a global scale. We are reinventing medical devices to leverage the health information in the human eye and championing a new era of healthcare by creating portable, affordable, easy to use, connected devices for early disease detection and monitoring. Tesseract is well-funded and recently raised a series B round of $80M.

We are part of 4Catalyzer - a rapidly growing health-tech incubator founded by Dr. Jonathan Rothberg, an award-winning scientist and highly successful serial entrepreneur. Our 4Catalyzer sister companies include Butterfly Network, the first whole-body Ultrasound-on-ChipTM, and Hyperfine, the first FDA-cleared portable MRI. We are fostering a culture of technical excellence and positive teamwork to solve real-world problems that help improve healthcare for billions of people around the world.

Joining Tesseract is the opportunity to redesign the future of healthcare through the power of technology. Join us on this journey to maximize global impact, motivated by the idea that our products will change lives, including the ones of people you love.

What We Live By

• Patients First. We are driven to make products that will improve people’s lives.
• Data-Driven. We search for the best solutions: objective, backed by data, and optimized for speed, simplicity and scale.
• Team-Oriented. We collaborate with and support each other every step of the way.

What You Will Be Doing

The Clinical Program Manager will be responsible for assuring a high level of quality, integrity and oversight for specific clinical programs by establishing a high degree of expertise in Tesseract’s developing technology, utilizing honed clinical operations skills, selecting and managing vendors, and leading/driving the internal team.

As part of our team, your core responsibilities will be to:

• Working under the direction of the Director of Clinical Operations, assist in designing, planning and executing clinical trials and other associated clinical activities
• Responsible for managing and executing clinical trials with an eye to quality, data integrity and patient safety within timelines determined by corporate milestones and adherence to appropriate regulatory requirements/guidelines
• Develop clinical study protocols and associated documentation including informed consent, case report forms, source documents, study tools and study training documents
• Execute exploratory/feasibility, pivotal, and post-market device clinical studies in a manner consistent with institutional, GCP, regulatory and compliance requirements
• Develop and maintain working relationships with KOLs, medical advisors, clinical sites, investigators and vendors 
• Oversee the development and implementation of investigator and clinical site personnel training, and as necessary, perform training and/or serve as a point of escalation for questions regarding ongoing clinical trials and/or real-time device use
• Oversee the development of source documents and eCRFs subject files in accordance with clinical testing policies and procedures. Ensure accuracy, completeness and HIPAA compliancy.
• Work with legal, research, and management to develop research agreements that define the scope and deliverables for research projects. Track budget, milestones, and deliverables throughout the project 
• Assist in the preparation for regulatory agency site visits. 
• Collect and communicate user and patient experiences with the devices and device interfaces. Maintain good notes on perceived optimizations, opportunities, features, form factor adjustments and communicate findings to internal team members
• Evaluate and recommend vendors involved in execution of clinical trials
• Manage the process of developing vendor agreements and work orders related to the trials you manage
• Track safety and other data trends to ensure all safety issues and data signals are evaluated, communicated internally to appropriate Tesseract team members, and to the IRB/FDA as required
• Review and approve invoices from vendors involved in activities related to ongoing clinical research
• Work hand-in-hand with the study team and document control personnel to manage documents related to the clinical study you manage
• Lead internal and external team meetings (as needed) regarding ongoing clinical research
• Work cross-functionally within Tesseract to ensure communication across all job functions to ensure the success of the clinical studies/programs you oversee

What We Are Looking For

Baseline Skills, Experiences, & Attributes:

• A minimum of 5-years of experience as a Clinical Project/Program Manager or equivalent combination of experience
• Bachelor's Degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology. Advanced degree is a plus.
• Prior experience with commercial medical product clinical research, the creation and execution of clinical projects, FDA validation, and understanding of clinical workflow towards product incorporation 
• Thorough knowledge and understanding of FDA and/or EMA regulations (or relevant local regulations), ICH Guidelines and GCPs governing the conduct of clinical trials 
• Ability to develop and project timelines and budgets
• Proficient in interpersonal communication skills, written and verbal for both internal and external entities; ability to present information and data within multiple settings
• Proven ability to work autonomously and self-sufficiently within a remote/virtual environment while able to identify areas of needed supplemental training/guidance to ensure overall success 
• Demonstrated ability to understand, evaluate and interpret data 
• Ability to interact professionally with all organizational levels 
• Ability to manage competing priorities in a fast paced and changing environment 
• Ability and willingness to travel up to 25% 

Preferred Qualifications

• 5 years of technical, hands-on clinical research monitoring experience (including pre-study, initiation, routine monitoring, audits and closeout visits) at a pharmaceutical, biotech, medical device, or CRO company
• Knowledge of ophthalmology and/or cardiovascular sciences is preferred but not required

What We Offer

• Fully covered medical insurance plan, and dental & vision coverage. As a health-tech company, we place great worth on our team’s well-being.
• Competitive salaried compensation & equity. You should feel appropriately valued and have a stake in our success!
• 401(k) plan. Everyone should be encouraged to save for their retirement adventures!
• Flexible PTO policy and remote/hybrid work arrangements. We believe in taking personal responsibility for managing our own time, workload and results. 
• Free onsite meals & kitchen stocked with snacks at our Guilford, CT campus. 
• Annual "Improve Your Work Environment" stipend. We support what you need to be your best self when at work!
• Professional development reimbursement. Let's grow together!
• More exciting employee perks... but most importantly, the opportunity to build a revolutionary healthcare product and save millions of lives! 

Tesseract does not accept agency resumes.

Tesseract is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.

Salary : $80 - $0