Manager, Process Development - Clinical Data Management

NYC

Flatiron Health expects our organization to meet high quality, ethical and operational standards.  We operate in a highly regulated space, with with defined requirements from the US Food and Drug Administration (FDA), Health and Human Services, Center for Medicare and Medicaid Services and others.  Delivering research projects within this environment require well defined and focused data management activities.

To that end, our Research Quality & Compliance team is seeking an experienced clinical data management 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 data management and lead the implementation of standard operating procedures (SOPs) against strategic priorities.  

Responsibilities:

  • Act as the subject matter expert (SME) and help define best practices for clinical data management including by not limited to clinical data lifecycle management (building, release, cleaning, locking and delivering), data management plan(s), oversight of third party data integrations/transfers, study reporting and electronic data capture (EDC).  
  • Provide hands-on clinical data management support for specific studies (e.g. ensure that data cleaning and delivery activities are completed on schedule) and during peak work periods (e.g. start-up, interim cleaning cycles, database lock).
  • Provide hands-on support for computer systems validation documentation (e.g. user acceptance testing, validation plans/reports, risk assessments for new software enhancements).
  • Provide proactive operational support regarding best practices, document control, process development/improvement and risk management for clinical data management.  Enhance and implement Flatiron’s clinical data management activities to ensure compliance with applicable regulatory requirements.  Monitor internal compliance with Flatiron’s internal procedures.
  • Foster a culture of clinical data management excellence focused on meeting high quality, ethical and data standards.
  • Design, implement and oversee clinical data management training plans for research staff.  Mentor cross-functional teams to help build core competencies for clinical data management.
  • Ensure that clinical data management 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 data management.

Requirements:

  • Experience as a leader in clinical data management (e.g. clinical data manager, data team lead) for multi-center, industry sponsored, interventional, clinical trials - preferably experience with global, phase III, oncology studies
  • At least six years of directly relevant experience of working within a highly regulated environment (e.g. pharma/biotech company, clinical research organization [CRO])
  • Experience drafting, reviewing, implementing and ensuring compliance with research procedures (SOPs) that drive efficiency and foster a creative approach to solving business needs
  • Proactive process development methodology that can translate complex regulatory principles into best practices for cross-functional clinical data management teams
  • A flexible approach to process development; ability to translate and infuse clinical data management knowledge and best practices for cross-functional teams
  • Strong working knowledge of regulations for clinical trials (specifically 21 CFR Parts 11, 312, 314, Good Clinical Practice [ICH-GCP E6 R2]).  
  • Experience with designing and implementing clinical data management training
  • Bachelor’s degree required
  • 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

Ideal Experience:

  • Direct, hands-on experience implementing data standards (specifically CDISC, CDASH, SDTM, ADaM)
  • Experience with clinical database integrations from real world data sources (e.g. electronic health records [EHR], electronic patient reported outcomes [ePRO], wearable sensors, electronic consent platforms [eICF])
  • Experience with computer systems validation (CSV) activities

Bonus Points:

  • Understanding of the global regulatory landscape (e.g. European regulations) and ability to apply global best practices to daily tasks
  • Oncology and/or clinical experience (e.g. nursing degree)
  • Scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications
  • Experience with designing protocols, case report forms, regulatory submissions, etc.
  • You’ve worked at a clinical research organization (CRO)
  • You’ve worked at a technology partner to a life sciences company