Senior/Principal CDM acts as a core team member of the Clinical Operations team.
The role includes a variety of tasks related to oversight and management of CRO partners to ensure Data Management work is completed on time, on budget and in compliance for multiple clinical trials.
Duties and Responsibilities:
· Working with the CRO, provide Data Management expertise and support to project teams using Data Management best practices
· Reviews study-specific Data Management Plans, procedures and guidance documents and provides feedback to CRO partners
· Performs QC activities on CRO work
· Provides functional support for study start-up
· Performs User Acceptance Testing of the Clinical database
· Reviews CRO metrics to identify trends, and drafts metrics slides for internal review boards.
· Reviews study-specific invoice unit trackers for accuracy of billing units for each IC project. Communicates questions related to units to CRO partner.
· Monitors planned versus actual consumptions and invoice units and escalates findings appropriately
· Reviews study-specific invoices against agreed upon invoice units tracker. Communicates any discrepancies and questions to applicable Clinical Trial Manager
· Follows-up on CRO corrective / preventive actions until resolution
· May attend study-specific core team meetings
· Identifies and appropriately escalate functional issues/concerns with CRO partners
· Supports a continuous state of audit readiness
· Collaborates with CRO on Data Management and trial operations improvements