Essential Functions of the Job:
• Lead studies within a program
• Oversee data managers working on studies either in-house or CRO/FSP resources
• Serves as active member of Clinical Study Teams.
• Collaborates with other functions to develop timelines and ensure that clinical data
management deadlines
• are met.
• Defines external data transfer specifications and works with external vendors in support
of timelines and data
• related deliverables.
• Ensures process is in place to review and reconcile lab data with lab normal ranges
• Develops or oversees development of eCRF and edit check specifications as necessary
to support data
• collection and analyses required by the protocol.
• Works closely with database builders during programming of EDC databases, edit
checks and reports.
• Drives and performs User Acceptance Testing (UAT) activities for clinical trial database
build and
• modifications.
• Develops or oversees development of study-specific eCRF Completion Guidelines and
Data Management
• Plans
• Creates and maintains data management documentation.
• Ensure data cleaning activities as specified in the Data Validation Specifications and
Data Management Plan.
• Works with coding group to ensure coding is applied to assigned clinical studies in
conjunction with study
• timelines and deliverables.
• Defines listings in support of data management, clinical and medical review of data.
• Identifies and troubleshoots operational problems, issues, obstacles, and barriers for
studies based on
• metrics data, audit reports, and input from other project team members.
• Will have the opportunity to drive all data review related activities. This will also include
identifying and
• escalating potential data issues to LDM when issues arise.
• Trains other personnel on eCRFs and EDC, as needed.
• Ensures coordination with Pharmacovigilance on serious adverse event reconciliation.
• Reviews and provides feedback on draft protocols, Statistical Analysis Plans, CSRs and
other documents as
• required.
• Support management team with continued process improvement/innovation for the
department and
• participates in the development and maintenance of Standard Operating Procedures
(SOPs) and Work
• Instructions related to data management activities.
• Will oversees data managers working on studies either in-house or CRO/FSP resources
to ensure studying
• the support on the studies are sufficient.
• Collaborates with program lead and other functions to ensure program-consistent, highquality
and on-time
• data delivery.
• May mentor other junior Clinical Data Managers.
• Other duties as assigned.