[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 simultaneous federal and state regulations coupled with defined requirements from the US Food and Drug Administration, Health and Human Services, Center for Medicare and Medicaid Services, and others.
To that end, Flatiron Health is seeking an experienced Research Quality & Compliance professional to define and drive Flatiron’s strategy with regard to adherence to the applicable regulatory requirements and enhance the quality system. This position will support Flatiron’s research initiatives in their efforts delivery high quality data and and to ensure compliance. Such support includes collaborating with key business, regional and functional 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 validation professionals at various levels as follows:
- Associate: Applicants with direct experience with completion of day to day compliance activities (e.g. document control, training plans, project support). Looking for at least 2 years of experience.
- 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 experience.
- 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 our Research-focused Product Management, Quantitative Science, Abstraction, Oncology, Security, Software Engineering and People Operations teams to draft, review and maintain research procedures.
- Directly relevant experience of working within a highly regulated environment within healthcare (e.g. life science company, contract research organization [CRO], etc.)
- Strong working knowledge of US FDA drug and/or biologic regulations and ICH-GCP guidelines. 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)
- 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
- 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
- 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
- Bachelor’s degree required
- Ability to work within cross-functional team and manage multiple simultaneous projects
- Intellectually curious, with outstanding problem-solving skills
- Nose for value; able to effectively prioritize in a challenging, time-sensitive environment
- Impeccable communication skills
- Passionate about our mission to improve healthcare through technology
- Experience conducting clinical trials at a clinical research site and/or experience as a study monitor/CRA, 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