The Clinical Data Manager III is responsible to participate the clinical data management activities for a project within a data management team; including processing of Case Report form and electronic data, processing and reconciliation of external data, SAE reconciliation and supporting the database close/lock procedures in accordance with our SOPs, Valuable Clinical Practice, ICH Guidelines and sponsor requirements. Work as a Project Point of Contact (POC), manage work allocation and work with minimal or no supervision.
Job Duties And Responsibilities
The specific job duties of a Clinical Data Manager III may include but are not limited to:
• For specified projects performs start-up activities including:
• Developing data management guidelines and study documentation
• Review of CRF design against protocol
• Lead study developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation. Activities include design, database structure, document creation; including approval
• For specified projects performs data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
• Study status tracking
• Review of data listings
• Identification of data issues and query generation
• Updating of database with query resolutions (paper studies only)
• Processing and reconciliation of external data including SAE reconciliation
• Ownership and proactive management of the data reconciliation activities documented in the DVP, DMP, etc.
• Provide input for Database closeout and lock activities and timelines
• Archiving of critical documents on an ongoing basis
• If assigned the Lead Data Manager role, act as key data management contact for the project.
• Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
• Proactively manage project quality through supervision and quality c