Manager, Process Development - Clinical Operations / Clinical Trial Management (CTM)

NYC

Flatiron Health expects our organization to meet high quality, ethical and operational standards.  We operate in a highly regulated space, 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 operations.

To that end, our Research Quality & Compliance team is seeking an experienced clinical trial management/operations 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 trial management/operations 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 operations including by not limited to clinical trial management (start up, maintenance, closure), oversight of third party vendors, communication planning, financial oversight (budgeting), recruitment strategy, study reporting and essential documents.  
    • When needed, provide hands-on clinical operations support for specific studies (e.g. ensure that key milestones are met).  Act as the back-up for clinical operations staff during peak work periods (e.g. start-up, interim cleaning cycles, database lock).
  • Provide proactive clinical operational support regarding best practices, document control, process development/improvement and risk management for clinical trial management/operations.  Enhance and implement Flatiron’s clinical operations activities to ensure compliance with applicable regulatory requirements.  Monitor internal compliance with Flatiron’s internal procedures.
  • Foster a culture of clinical operations excellence focused on meeting high quality, ethical and operational standards.
  • Design, implement and oversee clinical operations training plans for research staff.  Mentor cross-functional teams to help build core competencies for clinical trial management/operations.
  • Ensure that clinical trial management/operations 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 operations.

Requirements:

  • Experience as a leader in clinical operations (e.g. clinical project manager, lead clinical research associate [CRA], clinical 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 operation teams
  • A flexible approach to process development; ability to translate and infuse clinical operations knowledge and best practices for cross-functional teams
  • Strong working knowledge of regulations for clinical trials (specifically 21 CFR Parts 312, 314, Good Clinical Practice [ICH-GCP E6 R2]).  
  • Experience with designing and implementing clinical operations 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 with complex/novel study designs (e.g. adaptive, pragmatic, basket, umbrella, crossover trials)
  • Management/oversight of technology partners for clinical trials (e.g. electronic patient reported outcomes [ePROs], sensors, electronic diaries, electronic data capture [EDC])
  • Direct, hands-on experience with regulatory interactions (e.g. FDA meetings), regulatory submissions, post-approval commitments
  • Experience with safety reporting/pharmacovigilance (PV) regulations (e.g.

Bonus Points:

  • Understanding of the global regulatory landscape (e.g. European regulations) and ability to apply global best practices to daily tasks
  • Direct, hands-on experience with European good pharmacovigilance practices (GVP)
  • Direct, hands-on experience with late phase research (e.g. outcomes, phase III/IV, expanded access, label expansion)
  • 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