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Manager - Clinical Research Compliance and Regulatory Operations

Flatiron Health

Flatiron Health

Legal, Operations
Raleigh, NC, USA
Posted on Monday, March 4, 2024
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Manager, Clinical Research Compliance and Regulatory Operations


Reimagine the infrastructure of cancer care within a community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem.

We’re looking for a compliance professional 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?

What You’ll Do

The Manager will work with the teams within the Clinical Research Business Unit (CRBU) to support our research products and initiatives and the associated software development lifecycles. The Manager will function as a member of the Risk Management team and is responsible for management of in-process compliance and continuous improvement activities. Such support includes collaborating with key stakeholders and leadership. In addition, you'll also:

  • Provide in-process support to CRBU software engineering teams throughout the lifecycle (SDLC) to support compliance with FDA, EMA, MHRA, ISPE, and ICH requirements
  • Develop, standardize, and continuously improve applicable processes and procedures across the CRBU programs, as well as implement new initiatives with the rapidly growing team
  • Provide proactive support regarding research best practices, document management (including quality control [QC] checks), process development/improvement, change control, training, and risk management
  • Manage issue escalation, management, improvement plans, quality events, and corrective action and improvement plans within CRBU
  • Ensure audit readiness (internal and external) and support external audits/inspections as a Subject Matter Expert (SME), including coordinating responses and internal oversight of associated action plans (e.g. CAPAs)
  • Establish/maintain program development milestones and ensure accurate tracking and reporting of metrics and timelines in support of programs to ensure sustained inspection readiness
  • Liaison to Quality, Legal, Privacy, Compliance, and Security processes and programs

Who You Are

You're a proactive Research Quality professional with at least 3 years of applicable experience. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You’re a kind, passionate, and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact.

  • You have a Bachelor’s degree
  • You have direct knowledge and experience in a GxP environment with focus on GCP, GAMP5, ALCOA+
  • You have direct experience within a highly regulated environment (e.g. life science company, contract research organization [CRO], etc.) within healthcare, technology and/or research
  • You have direct experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs) as well as the associated training plans
  • You have experience with software defect, bug reporting and escalation in Agile development releases; proficiency in systems for detecting tracking (e.g. JIRA, BitBucket); experience with enterprise in-house developed and/or SaaS products
  • You have direct experience with audit preparation / management, preferably including GxP, Security (SOC2 Type II)
  • You have strong project management skills and the ability to work within cross-functional team and manage multiple simultaneous projects

Extra Credit

  • You have direct experience with process improvement methodologies
  • You have direct experience with international research regulations (e.g., European Union Clinical Trial Directive)

Where you’ll work

In this hybrid role, you’ll have a defined work location that includes work from home and 2-3 office days set by you and your team with the option of being Flex or Office. For more information on our approach to hybrid work as well as our work type options, 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.