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Coordinator, Integrated Quality Management

| Greater NYC Area

[Please note that this is an office based position at Flatiron's office in New York, NY]

Flatiron Health expects our organization to meet high quality, ethical, and regulatory standards. We operate in a highly regulated space, with defined requirements from the US Food and Drug Administration (FDA), Health and Human Services (HHS), as well as other state and federal requirements.

To that end, Flatiron Health’s Integrated Quality Management (IQM) team is seeking experienced research quality professionals to define, maintain, oversee, and optimize the quality management system. These positions will provide quality partnership across Flatiron Health’s business through quality management and quality oversight activities intended to accelerate quality improvement. This includes support for our research initiatives (e.g., human subjects protection) and partnerships with academic medical centers (e.g., scientific publications). Such support includes collaborating with key stakeholders to provide guidance on quality matters and lead the implementation of key elements of the quality program against strategic priorities.

We are looking for professionals at with experience with completion of day to day healthcare quality activities (e.g., data review, project tracking) and at least 2 years of experience.

Responsibilities (involvement will vary based on level):

  • Provide proactive quality support regarding research best practices, document control, process development/improvement, and risk management
  • Enhance, implement, and assess the health of Flatiron’s quality management system
  • Implement risk-based quality management activities focused on risk assessment, identification, escalation, and management. Guide and reconcile any associated corrective and preventive action plans
  • Foster a quality culture focused on meeting high quality, ethical and regulatory standards
  • Enhance and implement document control and training plans for research procedures in collaboration with internal teams
  • Design, implement, and oversee quality training
  • Ensure proactive audits/inspection readiness. Oversee external audits/inspections of Flatiron’s data and research businesses, including liaising with clients, hosting on-site visits, and internal oversight of associated action plans

Requirements:

  • Direct experience within a highly regulated environment (e.g. life science company, contract research organization [CRO], etc.) within healthcare, technology and/or research
  • Working knowledge of US FDA drug and/or biologic regulations. Familiarity with regulations and the associated guidance documents relevant to clinical trials (e.g. 21 CFR parts 50, 312, 812) and electronic data (e.g. 21 CFR Part 11)
  • Proactive quality support methodology that can translate complex regulatory principles into best practices for cross-functional research teams
  • A flexible approach to quality; ability to translate and infuse quality knowledge and best practices into research deliverables
  • Ability to work within cross-functional team and manage multiple simultaneous projects
  • Structured communication skills
  • Passionate about our mission to improve healthcare through technology

Bonus Points:

  • Experience in developing an organizational “culture of quality” and defining a quality management system
  • Experience drafting, reviewing, implementing and ensuring quality with research procedures (SOPs) that drive efficiency and foster a creative approach to solving business needs
  • Clinical trials and/or clinical research experience, such as oversight of multi-center clinical research activities including participant screening and recruitment, oversight of clinical research organization and/or vendors supporting research
  • Experience conducting clinical trials at a clinical research site and/or experience as a study coordinator, monitor (i.e. Clinical Research Associate), project manager
  • Understanding of the global regulatory landscape (e.g. European regulations) and ability to apply global best practices to daily tasks
  • Oncology experience
  • Clinical experience (e.g. nursing degree)
  • Scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications
  • Experience with designing protocols, case report forms, regulatory submissions, etc.
  • Experience with late-phase research such as phase 3B/4 trials
  • Experience with health outcomes and economic research
  • Experience with systems development life cycle (SDLC) and validation quality
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Technology we use

  • Engineering
    • .NETLanguages
    • C#Languages
    • C++Languages
    • JavascriptLanguages
    • PythonLanguages
    • jQueryLibraries
    • ReactLibraries
    • AngularJSFrameworks
    • ASP.NETFrameworks
    • Node.jsFrameworks
    • Microsoft SQL ServerDatabases
    • PostgreSQLDatabases

Location

Our office at One Soho is easily accessible and modern, and has all the amenities our employees need to be comfortable, productive and collaborative.

An Insider's view of Flatiron Health

What kinds of technical challenges do you and your team face?

An engineer and oncologist work together over several weeks to build an algorithm from a naive prototype to a highly specialized and flexible rule set that can accurately represent the lines of therapy for 95% of patients within a specific disease subset.

Abhishek

Software Engineer

How does the company support your career growth?

As engineering manager, I am invested in the professional development of the people I work with. I train team members by pulling them out of their comfort zones to the uncomfortable territory. At Flatiron, it is one of our values - greatness and comfort rarely co-exist.

Kevin

Software Engineer

What is your vision for the company?

At Flatiron, we believe that learning from the experience of every cancer patient is an imperative — it is the key to accelerating research and continuing to improve the quality of care. Our mission is to serve cancer patients and our customers by dramatically improving treatment and accelerating research.

Zach Weinberg

Co-Founder, President and COO

What's the biggest problem your team is solving?

Instead of studying the cells, I now have the opportunity to write about the patients. I can tell their stories through the research lens and enable them to advance clinical cancer research through their experiences. I certainly never lose sight of the human behind the cell anymore.

Rana

Medical Writer

What are Flatiron Health Perks + Benefits

Flatiron Health Benefits Overview

Flatiron has a holistic approach to employee experience. We promote a culture with wellness at the forefront.

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Intracompany committees
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Unconscious bias training
Diversity manifesto
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Family Medical Leave
Vacation & Time Off Benefits
Generous PTO
Paid Volunteer Time
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Free Daily Meals
Stocked Kitchen
Happy Hours
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
Diversity Program
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