Director, Clinical Data (Clinical Research)
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 Director of Data Capabilities, 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]).
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.
- 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.
- 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