Lead the management of CDM deliverables in coordination with internal and external cross-functional teams
Lead by providing CDM expertise for data coordination, collection, and cleaning to ensure high quality data
Perform the execution of end-to-end Data Management activities (e.g., eCRF development, Data Review, study lock)
Develop and manage data management timelines to meet study goals
Oversee External Data Management activities by providing project level support
Anticipate obstacles and difficulties of stakeholders and staff
Manage the development and finalization of CDM documents for the eTMF
Review and manage the eTMF for completeness and accuracy
Serve as a primary point of contact for Data Management activities
Ensure completeness, accuracy, and consistency of clinical data across all projects
Responsible for data review, query management, and metric report delivery to study teams
Coordinate study timelines and database snapshots for analysis and safety review meetings
Participate in internal audits as well as Health Authority audits
Participate in the development, review, and implementation of processes affecting CDM
Proactively provides input to continuous improvement activities within Clinical Data Management
Demonstrates efficacy in web-based Electronic Data Capture systems (e.g., Medidata Rave)

MS/MA in life sciences or related discipline and 4+ years of experience in Data Management OR
BS/BA in life science or related discipline and 6+ years of experience in Data Management OR
High School degree and 10+ years of experience in Data Management
Experience as independent lead in managing clinical data management deliverables for regulatory filings
At least 6 years of relevant industry experience with clinical trials
Experience in Industry Standards Guidelines (e.g., CDISC)
Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva EDC, Oracle, etc.)

Manager, Clinical Data Management

Key skills