Flatiron Health expects our organization to meet high quality, ethical and operational 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 and others. Delivering research projects within this environment require well defined and focused operations.

To that end, our Research Operations team is seeking an experienced clinical operations professional to define and drive Flatiron’s internal processes and training to ensure adherence with the applicable regulatory requirements (e.g. 21 CFR Parts 312, 314, Good Clinical Practice [ICH-GCP E6 R2]). This position will support Flatiron’s research initiatives in their efforts to deliver high quality data and and to ensure operational efficiency. Such support includes collaborating with key internal and external stakeholders to provide guidance on best practices for clinical trial management/operations and lead the implementation of standard operating procedures (SOPs) against strategic priorities. This position will be tasked with not only executing on a trial but identifying ways to increase the efficiency of a trial from the perspectives of sponsors, investigators, and patients, using Flatiron’s proprietary data and operational tools.

 Responsibilities:

• Oversee and deliver clinical operation activities including by not limited to
• Study management (start up, maintenance, closure)
• Oversight of third party vendors (ranging from CROs to technology partners)
• Communication planning
• Recruitment tracking
• Study reporting and essential documents.
• Create and maintain trial files
• Ensure that clinical operations activities embody proactive audit/inspection readiness.
• Collaborate with our Product Management, Quantitative Science, Abstraction, Oncology and Software Engineering teams to advise on the correct application of internal and external requirements for clinical operations.

Requirements:

• At least six years [At least 3 years for associate] of directly relevant experience of working within a highly regulated environment (e.g. pharma/biotech company, clinical research organization [CRO])
• Bachelor’s degree required
• Experience as a leader in clinical operations (e.g. clinical project manager, lead clinical research associate [CRA], clinical team lead) for multi-center, industry sponsored, interventional, clinical trials - preferably experience with global, phase III, oncology studies
• Strong working knowledge of regulations for clinical trials (specifically 21 CFR Parts 312, 314, Good Clinical Practice [ICH-GCP E6 R2]).
• Experience with designing protocols, case report forms, regulatory submissions, etc.
• 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

Bonus Points:

• Oncology and/or clinical experience (e.g. nursing degree)
• Scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications
• Experience at a technology partner to a life sciences company
• Experience as a clinical research field monitoring and/or data management experience for clinical trials