1. Oversee and manage (under project supervision of Associate Director, Data
Management, Senior Manager, Data Management or Manager, Data Management)
DM related activities outsourced to DM Vendors as well as other external data
sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up to
study close-out and final database lock/transfer while ensuring that all study
deliverables and milestones are met on time and within budget.
2. Identify and implement solutions to project data management issues and concerns,
including proactive prevention strategies based on metrics and forecasts
3. Participate (and Coordinate as needed) in the development of the clinical data model
and/or database design and annotate the CRF (eCRF) according to these
4. Review data acquisition conventions and data review guidelines / diagnostic
specifications consistent with the clinical data model, and CRF (eCRF) completion /
5. Develop and test data management system edit / data validation checks (diagnostics)
and special listings / procedures used as tools for the data review and discrepancy
6. Participate with the Study Operations Teams (SOTs) for all study activities, and lead
all DM functional activities using established FGN templates/processes as applicable.
7. Support the direction, planning, execution, collection and handling of all clinical data
to the highest quality standards.
8. Review study data for completeness and clinical sense. Assess the overall quality of
data and identify key data issues, trends or patterns that may pose overall study
compliance and/or data quality concerns, e.g., increased frequency of queries,
protocol deviations, and early treatment discontinuations.
9. Develop and manage the data review plan for each assigned study, including
maintenance and tracking of findings from all team members through issue resolution
and involving the data vendors as needed.
10. Ensure the receipt and proper filing, security and archiving of study related data, both
paper and electronic media, at all times.
11. Able to cultivate effective and productive working relationships with colleagues,
subordinates, vendors and management. Able to use clear judgment to solve
problems and to escalate issues with proposed solutions, as necessary.
1. Bachelor's degree in a relevant scientific discipline or equivalent
2. Minimum of 3 years of Data management experience in the pharmaceutical, biotech
and/or CRO industries, with experience in managing data from Phase III clinical
3. Skills present in core data management activities (e.g., Data Management Plans, data
edit specifications, understanding of database dictionaries/specs, electronic data
transfers, efforts/process in data quality assurance, use of medical coding
dictionaries). CCDM Certification a plus
4. Knowledge and experience with various clinical databases (e.g., Medidata RAVE,
Oracle InForm and key technologies (e.g., SAS, Scanning/Imaging, IVRS/IWRS,
5. Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
6. Phase I, II and III experience
7. Excellent communication, written and interpersonal skills
8. Proficiency with English language in an clinical research environment
9. Self-sufficient and able to work with minimal oversight