Senior Clinical Data Manager

• Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock

• Perform Project Management : represent DM on clinical teams, coordinate deliverables by other functions and/or CRO as necessary to achieve DM deliverables

• Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM,)

• Coordinate CRO data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution)

• Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed

• Serves as Project Data Manager for large projects or multiple smaller projects

• Conducts internal and external team meetings, including monthly project review meetings, representing Clinical Data Management

• Provides professional Data Management input on International Clinical Teams (ICTs)

• Responsible for ensuring consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects

• Coordinates and conducts setup activities, such as CRF design for complex trials, database structure design, CRF annotation, project document creation and/or approval, data entry screen design and testing, validation check creation, testing and approval

• Performs data management activities for studies conducted in-house; oversee and coordinate activities of CRO handling outsourced projects (protocol review, CRF development, database set-up activities, data validation process; medical coding, SAE recon)

• Provides input, review, and maintenance of global working practices and standards

• Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases

• Ensures appropriate Novartis tracking systems are up to date and accurate

• Serve as SME for SAE and PK reconciliation

• Leads and support clinical & non-clinical special projects. SIV & INV meeting participation for DM presentation.