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

We’re looking for a Clinical Data Manager to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care?

What You’ll Do

We are looking for Manager, Clinical Datato lead prospective real world (PrwS) studies for Flatiron’s Clinical Research business unit. This role will interact closely with members of Clinical Operations, Research Oncology, Abstraction, Abstraction Operations, Product Operations, Life Science Partners, and other key stakeholders within Clinical Research & Real World Evidence(RWE) . The role will report to the Head of Clinical Data Management.

• You will act as the point of contact for data management activities for multiple trials, provide oversight of data collection and management per regulatory and industry standards.
• Review CRFs to ensure alignment with protocol; perform acceptance testing(UAT) of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure
• Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy.
• Provide input to data quality checks programming and take action to ensure data quality
• Provide oversight of key Data management documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on Data Management expertise
• Analyze Data Management metrics, identify execution barriers, and propose solutions.
• Lead clinical data review and implement data review strategies using integration or visualization platforms.
• Understand the team as a whole - broadly, the Abstraction organization - and be proactive in driving team engagement and creating a great workplace for all.
• Own the scoping and enhancement of Flatiron-specific abstraction processes to meet the needs of Clinical Trial data management.
• Assist the Head of Clinical Data Management in client-facing capacity to support the scoping of Clinical Research studies and products.

This is a great opportunity for you to work with cross functional teams (e.g, Research Oncology, Product, Operations, Quantitative Sciences and Engineering) on research initiatives to develop high quality data products for delivery to clients.

Who You Are

You’re a kind, passionate and collaborative problem-solver who values the opportunity to think beyond the way things are. In addition, you’re a Clinical Data professional with extensive CRO and/or Sponsor experience in the biotech and pharmaceutical industry. 

• You have 5+ years of experience in clinical data management experience in biotech or pharma industry
• You have a Bachelor’s degree in science or related field
• You have significant experience leading data management activities for multiple clinical trials; proficient use of data management systems; advanced knowledge of data Management processes, tools, methodologies and documentation; strong understanding of data management strategy
• 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

Extra Credit

• You are familiar with SQL/Database concepts and programming with either SAS/R/Python etc.
• You have participated in observational or clinical research in Oncology
• You have at least 2 years’ direct people management experience
• 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

Where you’ll work 

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. For more information on our approach to hybrid work, please visit the how we work website.