Description:
Clinical Data Manager, Oncology is responsible for clinical data management activities for studies and ensuring FDA requirements for quality databases submissions are met. Perform and manage clinical Data Management (DM) activities for in-house and outsourced trials including protocol review, CRF (Case Report Form) development, database set up activities, data validation process (including manual data review of listings), and SAE (Serious Adverse Events) reconciliation, managing local laboratory and external labs and database lock. Represent DM on clinical teams, coordinate deliverables by other functions and/or CRO (Clinical Research Organization) 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 (Study Data Tabulation Model). Coordinate CRO (Clinical Research Organization) data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution. Perform user acceptance testing of the database using Inform. Design electronic Case Report Forms (eCRFs) for study start-ups. Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed
Responsible for resolving data issues from clinical, SDTM, and Biostatistical groups.
Job Qualifications Requirements
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. Also, some experience in supporting Oncology studies is a plus. Must be able to work independently and be proficient on all related regulations, GCP, and Good Clinical DM Practice. Project management skills are required and must also have strong oral and written communication skills. - Leadership skills is a must.
Knowledge of Standard global medical coding system MedDRA and WHODRUG.
Knowledge of the below systems and processes are a plus:
Clinical Data Management Systems related to EDC studies: Inform, RAVE, COGNOS, and JReview,
Clinical Data Management Processes; eCRFs design
Knowledge of CDISC and CDASH is a plus
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