Integrated Quality Management [Open Level]
[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 compliance standards. We operate in a highly regulated space, with defined requirements from the US Food and Drug Administration (FDA), Health and Human Services (HHS), Center for Medicare and Medicaid Services (CMS), and others.
To that end, Flatiron Health’s Integrated Quality Management (IQM) team is seeking experienced quality assurance (QA) professionals to define, maintain, and oversee the quality 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 community oncology (e.g., electronic health records [EHRs], insurance billing), research (e.g., human subjects protection), and/or academic medical centers (e.g., scientific publications) initiatives. Such support includes collaborating with key stakeholders to provide guidance on compliance matters and lead the implementation of key elements of the quality and compliance program against strategic priorities.
We are looking for professionals at various levels as follows:
Coordinator: Applicants with experience with completion of day to day research activities (e.g. data review, project tracking). Looking for at least 2 years of experience in healthcare, technology or a quality related field.
Lead: Applicants with direct experience with completion of day to day compliance activities (e.g. document control, training plans, project support). Looking for at least 4 years of direct experience in healthcare, technology or a quality related field.
Manager: Applicants with direct experience with oversight and strategy of compliance activities. Direct experience with thinking about how to create a compliance program. Looking for at least 6 years of direct experience in healthcare, technology or a quality related field.
Responsibilities (involvement will vary based on level):
- Provide proactive compliance support regarding research best practices, document control, process development/improvement and risk management. Enhance and implement Flatiron’s quality system to ensure compliance with applicable regulatory requirements. Assess internal compliance with Flatiron’s quality 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 compliance standards.
- Enhance and implement document control and training plans for research procedures.
- Design, implement and oversee compliance training.
- Ensure proactive audits/inspection readiness. Oversee all 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. Plan, facilitate, document and closure audits of Flatiron vendors.
- Collaborate with internal teams to draft, review and maintain procedures.
- 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 compliance support methodology that can translate complex regulatory principles into best practices for cross-functional research teams
- A flexible approach to compliance; ability to translate and infuse compliance knowledge and best practices into research deliverables
- Bachelor’s degree required
- Ability to work within cross-functional team and manage multiple simultaneous projects
- Structured communication skills
- Passionate about our mission to improve healthcare through technology
- Experience in developing an organizational “culture of compliance” and defining a quality system
- Experience drafting, reviewing, implementing and ensuring compliance 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 compliance