Raleigh-Durham
Reimagine the infrastructure of cancer care within a technology and science community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem.
We're looking for a Clinical Operations Manager to join our Prospective Studies, Client Solutions team within the Clinical Research Business Unit (CRBU) to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care and clinical research?
What You'll Do
We believe that traditional clinical research paradigms are ill-equipped to address the volume and complexity of research questions that face drug developers, researchers, and regulators. Flatiron's CRBU has, and is building, technology-first products and operations to support new approaches to prospective evidence generation and clinical trial execution to deploy our clinical research technology across a diverse set of top-tier academic medical centers and a broad network of community oncology clinics.
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In this role, you'll partner closely with Prospective Studies, Client Solutions and adjacent teams to develop and execute operational services that accelerate our clinical trial roadmap. You'll be in charge of managing active and planned real world prospective clinical studies. Such support includes collaborating with key stakeholders to provide guidance on clinical trial norms, best practices, and regulations (i.e., Good Clinical Practice [GCP]), and leading the execution of key elements of the operational and project management roadmap against strategic priorities.
In addition, you'll also:
- Primarily responsible for planning and managing ongoing and new prospective studies (e.g., developing a study timeline and budget, identifying dependencies and risks, executing against the timeline with Prospective Studies, Client Solutions and adjacent teams, managing the active phase of a study in conjunction with a study team, etc.).
- Identify and steer process development and process improvements across the clinical research organization intended to define, implement, and enhance fit-to-purpose research foundations based on regulatory requirements, industry best practices, and internal commitments.
- Represent Flatiron directly with life science partners primarily in Clinical Operations and Study Management; develop and foster strong working relationships with these stakeholders.
- Work directly with Flatiron product managers, software engineers, and adjacent teams to bring new trial opportunities to life. Develop, execute, and refine software and operations intended to drive efficient studies with transparency and cost reduction across the clinical trial spectrum.
- Use your background in study management, site startup, and study execution to find flexible, efficient solutions based on regulatory requirements and industry best practices.
- Provide proactive support that pairs complex regulatory requirements with business goals for cross-functional research teams.
This is an opportunity to use your experience in the way things are "routinely" done in clinical trial operations to find new ways to approach common inefficiencies. Our team is passionate about pairing technology with streamlined operational support to move the needle on drug development in oncology.
Who You Are
You're a kind, passionate, and collaborative problem-solver who values the opportunity to think beyond the way things are. In addition, you're a proactive clinical trial operations professional with 5+ years of direct experience with execution and oversight of multi-site clinical studies from end to end (i.e., from trial startup to closeout). You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. Specifically, you:
- Have direct, subject matter expertise in multi-site clinical trial operations management including:
- All study planning activities and direct experience working across different study execution teams.
- All processes associated with site startup (e.g., processes for site identification, feasibility, selection, essential regulatory documentation, budgets and trial agreements, activation, etc.)
- Active study management processes (e.g., recruitment management, site management, etc.), and study closeout
- Have managed clinical trials representing a life science partner (e.g., life science company or biotech) or a Clinical Research Organization (CRO)
- Have direct experience managing study vendors
- Have direct subject matter expertise in Good Clinical Practice (GCP), Food and Drug Administration (FDA) drug, device, and/or biologic regulations (e.g., 21 CFR parts 11, 50, 312, 314, 812, 814, 820)
- Have a flexible approach to execution; ability to translate/infuse experience, knowledge, and best practices into research deliverables with creative solutions
- Have the ability to work within cross-functional teams and manage multiple simultaneous projects
- Are proactive, self-motivated and self-directed, detail-oriented, comfortable with ambiguity, and data driven
- Have exceptional written and verbal communication skills that can be tailored to leadership and project teams
- Are passionate about our mission to improve healthcare through technology
- Share our commitments to diversity, inclusion, and belonging; You are excited to use your skills to optimize quality in new and innovative ways
If this sounds like you, you'll fit right in at Flatiron.
Extra Credit
- You have experience managing oncology clinical studies
- You are or have been a clinical trial monitor (e.g., a Clinical Research Associate [CRA])
- You have direct experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs) as well as the associated training plans
- You have managed clinical trial budgets and/or contracts
- You have worked for a technology company or have worked directly with software developers and product managers
- You have experience with health outcomes and economic research, epidemiology, and/or late-phase clinical trials (e.g., Phase 3B/4)
Where you'll work
In this hybrid role, you'll have a defined work location that includes work from home and 3 office days set by you and your team. For more information on our approach to hybrid work, please visit the how we work website.
Flatiron Health is proud to be an Equal Employment Opportunity employer.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.