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Manager, Clinical Trial Operations

  • Anywhere

Company :
Flatiron Health

Location :
New York City, New York

Expiry Date :
Sun, 07 Mar 2021 23:59:59 GMT

Apply Job :
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Description :
We’re looking for a Clinical Trial Operations professional to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Here’s what you need to know about the role, our team, and why Flatiron Health is the right next step in your career. What You’ll Do In this role, you’ll work with Clinical Operations and adjacent teams to develop and execute operational services that accelerate our clinical trial roadmap. Reporting to the Senior Manager, Clinical Operations, you’ll be in charge of creating and executing on wraparound services that support a suite of novel trial enabling software products. 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 roadmap against strategic priorities. In addition, you’ll also: Plan, conduct, and oversee detailed assessments of Flatirons site network; communicate and work directly with site trial and clinical staff; develop and oversee Flatirons site network profile, and communicate both detailed and summary-level information to internal leadership and clients. Identify and steer process development and process improvements across the trials 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 enablement products 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 recruitment management 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 proactive clinical trial operations professional with at least 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. Youre a kind, passionate, and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact. You have direct, subject matter expertise in multi-site clinical trial operations management including: 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 You have managed oncology clinical trials representing a life science partner (e.g., life science company or biotech) or a Clinical Research Organization (CRO) You 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) You have a flexible approach to execution; ability to translate/infuse experience, knowledge, and best practices into research deliverables with creative solutions You have the ability to work within cross-functional teams and manage multiple simultaneous projects You have structured communication skills that can be tailored to leadership and project teams You are passionate about our mission to improve healthcare through technology You share our commitments to diversity, inclusion, and belonging; You are excited to use your skills to optimize quality in new and innovative ways Candidates outside of NYC will be considered provided that they can periodically travel to the NYC office (pending pandemic related health/safety precautions) If this sounds like you, you’ll fit right in at Flatiron. Extra Credit You are or have been a clinical trial monitor (e.g., a Clinical Research Associate [CRA] and/or a study manager 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 experience with international research regulations (e.g., European Union Clinical Trial Directive) 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) You have clinical experience Why You Should Join Our Team A career at Flatiron is a chance to work with everyone involved in the future of cancer care and researchall under one roof. Researchers, data scientists, designers, clinicians, technologists and many more all work together to improve cancer care and accelerate research. At Flatiron, we strive to build and maintain an environment where employees from all backgrounds are valued, respected and have the opportunity to succeed. You’ll also find a culture of continuous learning, broad and inclusive employee support offerings, and a commitment to supporting our team members in all aspects of their livesat home, at work and everywhere in between. We offer: Flatiron University training curriculum which includes presentation skills, meeting mastery, coding languages and more Career coaching opportunities Hackathons for all employees (not just our engineers!) Professional development benefit for attending conferences, industry events and external courses Work/life autonomy via flexible work hours and flexible paid time off Generous parental leave (16 weeks for either parent) Back-up child care Flatiron-sponsored fitness classes 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.