Research 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 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 various levels as follows:
-Coordinator: Applicants with experience with completion of day to day healthcare quality activities (e.g., data review, project tracking). Looking for at least 2 years of experience.
-Lead: Applicants with direct experience with completion of day to day research quality activities (e.g. quality monitoring/auditing, project support, implementing changes in regulations). Looking for at least 4 years of direct experience.
-Manager: Applicants with direct experience with oversight and strategy of research quality activities. Direct experience with thinking about how to create a quality program. Looking for at least 6 years of direct 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
- 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
- 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