Senior Clinical Data Manager,Oncology
Project Data Management level.
Perform DM activities for in-house and outsourced trials: protocolreview, CRF development, database set up activities, data validation process(including manual data review of listings), SAE reconciliation, managing locallaboratory and external labs and database lock. normal">Perform Project Management: represent DM on clinical teams, coordinatedeliverables by other functions and/or CRO as necessary to achieve DMdeliverables. Coordinate with Programming team to provide support to the data reviewand safety updates (coordinate generation of data review listings, dataretrieval to support data review and analysis, SDTM,) Coordinate CRO data validation activities (coordinate data transferspecs, data reconciliation, query generation and resolution, Participate in the development and implementation of departmentstandards and documents, and other data management, departmental activities asneeded.
Bachelor degree or above in scientific or related field Minimum 5-7 years’experience in Data Management with experience in managing projects, projectteams. Experience with In-Form or other EDC software is desirablehowever, should have some experience in supporting normal">Oncology studies. Must be able to work independently. Proficiencyon all related regulations, GCP, and Good Clinical DM Practice. Projectmanagement skills required. Strong oral and written communication skills. -Leadership skills a must
Best Regards
Mohd Shadab
732-429-1631
Job details are sourced from the employer's original posting.
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Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.