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Flatiron Health

Director, Clinical Data (Clinical Research)

New York, NY / Remote

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

We're looking for a Director of Clinical Data Management to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Are you ready to be the next changemaker in cancer care?

In this role, you'll work with the Clinical Data team in our Clinical Research Business Unit (CRBU) in support of data products and services intended to disrupt traditional clinical research through delivery of high quality data and operational efficiencies. Reporting to the Senior Director of Data Capabilities & Operations, you'll be responsible for defining and executing Flatiron's clinical data management processes for prospective evidence, ensuring fit-for-purpose data quality and compliance with the applicable regulatory requirements (e.g. 21 CFR Parts 312, 314, Good Clinical Practice [ICH-GCP E6 R2]).

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You will collaborate with key internal and external stakeholders to provide guidance on best practices for data management for new and enhanced product offerings as well as design, specification, creation, and testing of project specific clinical databases, data capture forms, and incorporation of real-world data.

What You'll Do

  • Lead the Clinical Data team staffed to the Clinical Research Business Unit, including developing and maintaining core processes, managing a team of Clinical Data Managers/Analysts, shaping and growing the Clinical Data function, and ensuring the success of data deliverables.
  • Oversee and provide data management support for a portfolio of clinical studies leveraging a diverse range of data sources.
  • Develop and implement innovative study data management processes with standard operating procedures (SOPs) and work instructions to create case report forms, edit check specifications/data validation, data management plans (DMP) and data quality plans, conduct data review and cleaning activities, user acceptance testing (UAT) of electronic data capture (EDC), support study design and database development, document control, risk management, and reporting to ensure compliance and audit/inspection readiness with applicable requirements.
  • Apply data management expertise and knowledge of data standards to identify use cases and requirements that data management software applications and operational products/study concepts must support.
  • Shape Flatiron's best practices and influence clinical research data management standards through knowledge of clinical literature, regulations, standards, new technologies, and industry-leading trends, presenting at professional conferences, or publishing in professional journals.
  • Engage with external stakeholders (study sponsors, regulatory agencies, alliance partners, KOLs, etc.), to understand their requirements for data operations and align on the use of Flatiron data and products in clinical research.
  • Collaborate with our Clinical Operations, Product Management, Quantitative Science, Research Oncology, and Software Engineering teams to advise on the correct application of internal and external requirements for study data management.

Who You Are

You're a kind, passionate and collaborative problem-solver who values the opportunity to think beyond the way things are. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day.

  • You have 7+ years of clinical data management experience working at a pharma/biotech company or at a clinical research organization (CRO) or in a role responsible for building and delivering data management services to pharma clients
  • You are a proven team leader, with 3+ years of people management experience, who delegates, aligns, and holds team members accountable for results in a highly dynamic and fast-paced environment
  • You have a Bachelors or Masters degree in a management or operations field, science or healthcare related field, or equivalent practical experience
  • You have a demonstrated understanding of clinical data capture/management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC, EHR, eCOA, CDR, MDR, and adjacent systems.
  • You have strong working knowledge of clinical study processes and related regulatory requirements or information governance frameworks, (e.g. 21 CFR Parts 11, 312, 314, Good Clinical Practice [ICH-GCP E6 R2], Good Clinical Data Management Practices, HIPAA)
  • You have experience collaborating cross-functionally, such as with technical experts, clinicians, scientists, operations, and regulatory professionals, to apply and adapt data management practices.
  • You have experience as a functional leader in managing delivery of multiple traditional clinical studies with a strong understanding of project staffing, customer negotiations, data management team structures, design of clinical case report forms, and regulatory submissions (i.e. NDAs, BLAs or equivalent)
  • You have direct, hands-on experience implementing pharmaceutical industry health data standards such as CDISC (CDASH, SDTM, ADaM) and medical coding processes, systems, and dictionaries (MedDRA and WHO Drug).
  • You bring empathy and a high degree of sensitivity to understanding, shaping, and integrating external stakeholder perspectives of converging EHR and industry regulatory data standards in support of Flatiron's products and clinical research activities
  • You have intermediate competency in SQL and relational database design
  • You have a fundamental knowledge of statistics and experimental design

Extra Credit

  • You have experience with integrating clinical data from real-world data sources, such as EHR, ePRO, wearable devices, and/or experience managing data for real-world evidence programs, registries, or other post-marketing studies
  • You have some experience SAS, R, Python, or other statistical tools
  • You have experience in study data management for global, multi-center, industry-sponsored clinical studies
  • You have experience working with legacy Protocol First (now Flatiron Health) clinical trial products: EDC+ (now Vessel) and Clinical Pipe
  • You have experience working at a startup, technology partner to a life sciences company, and/or experience working in a highly cross-functional environment
  • You have experience working with oncology data and studies
  • You have experience managing other people managers
  • You are familiar with machine learning model development
  • You have an advanced degree in biomedical science, informatics, biostatistics, or relevant experience

Where you'll work

In this remote position, you have the freedom to choose your preferred work location while aligning your working hours with your team's. For further details on our hybrid work approach and remote work type, please visit the how we work website.

Life at Flatiron

At Flatiron Health, we offer a full range of benefits to support you and your loved ones so you can focus your working hours on improving cancer care and accelerating cancer research, and your non-working hours on everything else life has to offer:

  • Work/life autonomy via flexible work hours and flexible paid time off
  • Comprehensive compensation package
  • 401(k) contribution to help you reach your retirement planning goals
  • Financial health resources including 1:1 financial advice
  • Mental well-being tools and services
  • Parental benefits and policies including family-building care and generous leave
  • Path to parenthood programs supporting fertility, adoption and surrogacy
  • Travel support for safe healthcare services
  • Lifestyle spending account for perks that make sense for you and your family

In addition to our robust benefit offerings, visit our Life at Flatiron page to learn how we support continuous learning through professional development programs and celebrate Diversity in the workplace.

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.

Job Compensation Range

Preferred Primary Location: NYC Headquarters

Salary Range: $176,000.00 - $264,000.00

An important note on salary

The annual pay range for this position is based on the preferred primary location of the role which is listed above.If you are applying to this role at a location that is not the preferred primary location, please keep in mind the salary range will vary and may fall outside of what is listed. Base pay offered may vary depending on job-related knowledge, skills, and experience. An annual bonus and equity may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the position offered.

Client-provided location(s): New York, NY, USA
Job ID: Flatiron_health-4871378
Employment Type: Other

Perks and Benefits

  • Health and Wellness

    • FSA
    • HSA
    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • Health Reimbursement Account
    • Mental Health Benefits
  • Parental Benefits

    • Fertility Benefits
    • Family Support Resources
    • Birth Parent or Maternity Leave
  • Work Flexibility

    • Flexible Work Hours
    • Remote Work Opportunities
    • Hybrid Work Opportunities
  • Office Life and Perks

    • Company Outings
    • Commuter Benefits Program
    • Casual Dress
    • Pet-friendly Office
    • Happy Hours
    • Snacks
    • Some Meals Provided
  • Vacation and Time Off

    • Personal/Sick Days
    • Paid Holidays
    • Unlimited Paid Time Off
    • Paid Vacation
    • Leave of Absence
  • Financial and Retirement

    • Relocation Assistance
    • Performance Bonus
    • Stock Purchase Program
    • 401(K) With Company Matching
  • Professional Development

    • Promote From Within
    • Mentor Program
    • Shadowing Opportunities
    • Lunch and Learns
    • Tuition Reimbursement
    • Internship Program
    • Leadership Training Program
  • Diversity and Inclusion

    • Diversity, Equity, and Inclusion Program
    • Employee Resource Groups (ERG)
    • Woman founded/led

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