Full-Time

Manager – Clinical Research Compliance and Regulatory Operations

Flatiron Health

Flatiron Health

1,001-5,000 employees

Improving healthcare by learning from the experience of cancer patients

Data & Analytics

Junior, Mid, Senior

Research Triangle, Durham, NC, USA

Required Skills
Agile
Management
Git
JIRA
Google Cloud Platform
Requirements
  • Bachelor’s degree
  • Direct knowledge and experience in a GxP environment with focus on GCP, GAMP5, ALCOA+
  • Direct experience within a highly regulated environment (e.g. life science company, contract research organization [CRO], etc.) within healthcare, technology and/or research
  • Direct experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs) as well as the associated training plans
  • 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
  • Direct experience with audit preparation / management, preferably including GxP, Security (SOC2 Type II)
  • Strong project management skills and the ability to work within cross-functional team and manage multiple simultaneous projects
Responsibilities
  • 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

Flatiron seeks to identify and solve problems that drive work that moves the needle for customers and patients. In short, they seek to learn and improve cancer research from each patient.

Company Stage

M&A

Total Funding

$2.2B

Headquarters

New York, New York

Founded

2012

Growth & Insights
Headcount

6 month growth

-1%

1 year growth

1%

2 year growth

19%

Benefits

Work/life autonomy via flexible work hours and flexible paid time off

Generous parental leave (16 weeks for either parent)

Transition back to work program following parental leave

Child and caregiver travel benefits for new parents

Backup child care

Weekly meditation sessions

Flatiron-sponsored fitness classes

Weekly massages and manicures available onsite (employee funded)