Lead Data Analyst

Summary

Join Flatiron Health as a Lead Data Analyst, Clinical Data Management and contribute to their mission of improving and extending lives by learning from the experience of every person with cancer. This role involves leading prospective real-world (PrwS) studies for the Clinical Research business unit, collaborating with various stakeholders, and managing data management activities for multiple studies. You will be responsible for study design, CRF creation, EDC build, data collection oversight, data quality assurance, and reporting. This position offers the opportunity to work with cross-functional teams on research initiatives to develop high-quality data products for clients.

Requirements

• You have 4+ years of experience in clinical data management in biotech or pharma industry
• You have a minimum of Bachelor's degree in science or related field
• You have experience leading data management activities for multiple clinical trials; proficient use of data management systems; knowledge of data Management processes, tools, methodologies and documentation
• You have experience and understanding of GCPs, SOPs, regulatory requirements and good data management (GCDMP) practices
• You have experience with CDISC standards (SDTM, CDASH) & data collection requirements preferably in oncology trials
• You have experience working with clinical trial study Monitors, clinical trial data entry. This includes data discrepancy queries and the steps needed to resolve
• You have strong project management skills, organizational, and analytical skills
• You have excellent verbal and written communication skills with demonstrated experience engaging and influencing cross-functional teams
• You have a nose for value; ability to effectively prioritize in a challenging, time-sensitive environment
• You have ability to work within cross-functional team and manage multiple simultaneous projects

Responsibilities

• Manage, maintain and act as the point of contact for data management activities for one or more studies, including providing input to study design, CRF creation, EDC build & oversight of data collection and management per regulatory guidelines and industry standards
• Provide input to protocol, creation of study CRFs/specifications, CRF Completion Guidelines(CCGs) and EDC build including edit checks, testing, etc
• Assist the creation of the study Data Review Plan (DRP) and execution of integrated data quality & oversight processes using risk-based methodologies (RBM) via cross-functional collaboration (Medical Monitoring, Study Monitoring, Safety Monitoring etc.)
• Provide oversight of key data management documentation (e.g., Standard Operating Procedures, Work Instructions, data flow diagrams, etc.) to ensure inspection readiness & alignment with industry best practices
• Collect/Analyze/Report data management metrics, identifying execution barriers/risks and propose solutions
• Understand the team as a whole and be proactive in driving team engagement and creating a great workplace for all
• Assist in client-facing capacity to support the scoping and execution of Clinical Research studies and products

Preferred Qualifications

• Previous experience from regulatory submissions to provide input to building processes, infrastructure & governance models for end-to-end clinical data flow (e.g., protocol, data collection, tabulation (e.g., SDTM), Analysis (ADaM/TLFs), study reporting(CSR/Synopsis), e-submissions
• You are familiar with SQL/Database concepts and programming with either SAS/R/Python etc
• Experience with clinical data review and implement data review strategies using integration or visualization platforms
• You have participated in observational or clinical research in oncology
• You have a comfort level with technology and familiarity with EMR systems and EDCs, including the ability to recommend system improvements and interact with engineering staff

Benefits

In this hybrid role, you’ll have a defined work location that includes work from home and 3 office days set by you and your team