Clinical Study Manager

Quanterix is a company on a mission to change the way in which healthcare is provided by enabling researchers and clinicians to closely examine the continuum from health to disease. In our focused therapeutic areas, our revolutionary technology, Simoa®, is helping advance the science of precision health. Simoa® is changing the way in which the biology of health and disease is studied by giving researchers the ability to measure critical biomarkers in therapeutic areas including neurology, infectious disease, oncology, inflammation, and cardiology. To continue our extraordinary growth, we are seeking a Clinical Study Manager. Responsibilities include the oversight and execution of product registration studies, feasibility studies, post-launch studies and collaboration with medical facilities and clinical research organizations to lead sample acquisition and biobanking in support of R&D and service laboratory activities.

What You’ll Do:

• Participation on cross functional project teams to provide strategic and tactical guidance to meet US FDA and EU IVDR clinical requirements.
• Protocol and report development to ensure compliance and alignment with study objectives.
• Lead IRB engagement, including study protocol development, consenting protocols, IRB approval process, study closure etc.
• Initiate, coordinate, and take responsibility for developing supporting documents (such as informed consent, case report forms, etc) related to study conduct, including source documentation, monitoring, study guidelines, and training materials to assure compliance with regulatory requirements and alignment with study objectives.
• Monitoring clinical study conduct at internal and external site(s).
• Provide regular reports to internal and external Data Safety Monitoring Committees.
• Lead sample acquisition and biobanking activities for IVD initiatives.
• Conduct remote data monitoring and on-site visits (training, monitoring, close-out) in accordance with Federal regulations, ICH Good Clinical Practices guidelines and standard operating procedures.
• Development of global clinical plans for IVD products.
• Planning, executing, and managing clinical projects.
• Maintain up-to-date knowledge of IVD regulations and applicable guidance’s, monitor development of regulations and communicate impact to the business
• Establish professional rapport and frequent communication with clinical study site personnel.

What We’ll Expect From You: 

• Bachelors Degree in life science or a medical discipline.
• Minimum of 5 years experience in a Clinical, Regulatory or Quality role.
• Training and certification in the conduct of human subjects research
• Excellent understanding of ICH Good Clinical Practices.
• Ability to travel up to 20-25% of the time, or as circumstances dictate.
• Demonstrated ability to understand and interpret clinical data and literature.
• Excellent interpersonal, verbal and written communication skills.
• Excellent time management, organizational, negotiation, and project management skills.
• Ability to work independently

Why You’ll Like Working For Us: 

Our Technology: Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.

Our Commitment To Employees: We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free bagels every Monday morning, and free snacks and drinks every day! Quanterix hosts Virtual Bingo nights with all employees when we can see families, pets, and win amazing prizes. In addition to competitive compensation and a 401k plan with an employer match, we offer competitive health, dental, and vision benefits for employees and their dependents. We offer a Flexible Spending Account (FSA), Life, Disability, and Accidental Death & Dismemberment Insurances, and Mental Health Care, we offer generous Maternity & Paternity leave, Family Medical Leave, Fertility Assistance, Dependent Care, Military Leave and Vacation Carryover. All employees are awarded Equity, an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. 

Our Culture: Quanterix is committed to a Diverse and Inclusive workplace. We have a Diversity Program with Executive Sponsorship. Our core values are Accountability, Teamwork, Trust, and Transparency OR ATT2. Meet some of our team HERE. Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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