Ergomed
Location
Mumbai | India
Job description
The Lead Data Manager (LDM) within the ERGOMED Data Management (DM) department is responsible for providing oversight of all DM parts of a project from study start-up to database lock by working in a collaborative team environment with all functional groups.
The Lead Data Manager represents a position under direction of the Director of Data Management.
Provide updates for Data Management during internal/client team meetings and communication if required.
Provides metric reports for internal/external project team
Meets with the Project Manager to work on completing the study objectives in a timely manner
Provides training of other DM staff on project specific processes
Provides feedback to other project team members and managers to improve the deliverables
Authors or reviews data management documentation including the Data Management Plan,
Data Review Plan, eCRF Completion Guidelines, and others as needed
Supports design and testing of EDC study designs
Creates listings/reports using ad hoc reporting tools across multiple EDC systems
Communicates any project risks or possible quality issues to the Project Manager
May work on projects across multiple trial EDC platforms
Maintains project files and ensures full traceability of all processes and documentation
Manages Lab ranges across the entire study
Performs data management activities such as data review, serious adverse event reconciliation, third party electronic data (e.g. laboratory, PK, diary) reconciliation, and query management
Oversees the issuing of queries and reviews query responses with the highest level of quality
3-5 years of relevant experience in pharmaceutical industry and/or contract research organization, specifically in data management.
Experience in working with EDC systems (e.g. IBMCD, Medrio, Medidata RAVE, iMednet, Datatrial) Proficiency in computer applications: Windows, Excel, Word, Outlook etc.
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