Improve and extend lives by learning from the experience of every person with cancer through effective clinical data management.
Requirements
- Proficient use of data management systems
- Knowledge of data Management processes, tools, methodologies and documentation
- Experience with CDISC standards (SDTM, CDASH) & data collection requirements preferably in oncology trials
- Experience with GCPs, SOPs, regulatory requirements and good data management (GCDMP) practices
- Familiarity 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
- Comfort level with technology and familiarity with EMR systems and EDCs
Responsibilities
- Manage, maintain and act as the point of contact for data management activities for one or more studies
- 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
- 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
- Assist in client-facing capacity to support the scoping and execution of Clinical Research studies and products
- Lead prospective real world (PrwS) studies for Flatiron’s Clinical Research business unit
Other
- 4+ years of experience in clinical data management in biotech or pharma industry
- Minimum of Bachelor's degree in science or related field
- Strong project management skills, organizational, and analytical skills
- Excellent verbal and written communication skills with demonstrated experience engaging and influencing cross-functional teams
- Ability to effectively prioritize in a challenging, time-sensitive environment
- Ability to work within cross-functional team and manage multiple simultaneous projects
