Sr Clinical Data Manager, Clinical Data Management

Responsible for the direct management and oversight of data management activities for assigned studies. Work in conjunction with the study team to ensure data review, project support, study document management and oversight of DM timelines, EDC/IWRS setup, study database design, clinical data capture, discrepancy management and data reconciliation. Primary point of contact between Data Management and the clinical team with respect to the management and oversight of data management activities. Author, review/revise Data Management related study plans including Data Management Plan, Data Validation Plan, Data Review Plan, CRF Completion Guidelines and other study documents to ensure quality and standardization. Collect approvals and provide authorization on DM deliverables including but not limited to finalized DM documents, database release to production and database lock. Work with vendor(s) particularly to support the DM tasks such as transfer of data. Manage design and development of eCRFs, including database UAT. Oversee and manage the development and implementation of edit check specifications and work with database programmers during programming and validation. Manage and oversee data management related activities for the ongoing study. Lead DM study meetings; distribute agenda, create minutes capturing action items and decisions. Lead data reviews with clinical team to ensure accuracy, consistency and reliability of data. Review database metrics and follow escalation process to achieve resolution of noted issues. Collaborate with study team to ensure study databases are locked based on pre-defined criteria and timelines. Ensure that CDM procedures and processes meet business requirements and are adhered to in a consistent manner. Provide high quality services through efficient and compliant processes.