Title: Senior Clinical Data Manager, Oncology
Term: 1 year, possible extensions
Location: Remote until permissible, then all work in Bergen County, NJ office
Project Data Management level
- 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.Required:
- 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 however, should have some experience in supporting Oncology studies.
- Must be able to work independently.
- Proficiency on all related regulations, GCP, and Good Clinical DM Practice.
- Project management skills required. Strong oral and written communication skills.