Senior Clinical Data Manager (Park Ridge, NJ)

Primary Responsibilities:

-Perform data management 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
-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

Bachelor degree or above in scientific or related field
-Minimum 5-7 years experience in Data Management with experience in managing projects, project teams
-Experience with In-Form or other EDC software is desirable
-Proficiency on all related regulations, GCP, and Good Clinical DM Practice
-Project management skills required

Type: Long-term Contract