Clinical Data Manager

  • Anywhere

Company :
TechData Service Company LLC

Location :
Woodcliff Lake, New Jersey

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Description :
Clinical Data Manager needed in Woodcliff Lake – 3445 BB3445 Woodcliff Lake, Job_Description 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. Requirements Bachelor s 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 a must 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 Knowledge of Standard global medical coding system MedDRA and WHODRUG. Show moreShow less Show moreShow less