Clinical Data Manager

The CDM will be responsible for developing data management plans and quality management plans that will deliver accurate, timely, consistent and quality clinical data.


  • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
  • Serve as the project and client liaison to CROs including management and provision of project specific data management status, cycle time, and productivity metrics
  • Coordinate and participate in the development of the clinical data model and/or database designs and annotate the CRF (eCRF) according to the specifications
  • Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, statistical analysis plans, and CRF (eCRF) completion / monitoring conventions
  • Coordinate the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
  • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality
  • Be responsible for advanced planning and risk management for projects (issue escalation, resource management)
  • Oversee the technical performance of the data review project staff at CRO through delivery of quality data, on-time and on-budget
  • Assist with objectives for data review by CRO
  • Maintain technical data management competencies via participation in internal and external training seminars
  • Oversight of CRO staff training and adherence to project-specific, global, standardized data management process
  • Collaborate with CRO on areas for process and efficiency improvement and implement solutions on assigned projects
  • Review literature and research technologies/procedures for improving data management practices for the Company in collaboration with CRO
  • Perform other data management duties such user acceptance testing, data listing reviews, data trend reporting, timeline confirmation for database lock, etc.


  • Bachelor’s degree in business, computer science, math, science or a related field
  • 5+ years relevant experience in a CRO, biotechnology or pharmaceutical company
  • Broad knowledge of the drug development process
  • Understanding of global clinical development budgets Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
  • Knowledge of SAS preferred
  • Knowledge of time and cost estimate development and pricing strategies for data management services, EDC vendor selection, ancillary database transfers
  • Ability to manage multiple projects/priorities
  • Excellent oral and written communication skills
Job Type
Full-Time Regular
Boston MA