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Senior Data Manager

New Jersey All, NJ

Posted: 12/04/2019 Job Type: Clinical Job Number: JN -122019-26070 Region: New Jersey All

Job Description


1. Manage outside CROs and consultants:

Perform QC of CRO activities to include query management, data review, DM documentation such as edit checks, lock process

Monitor progress of data management activities by CROs

Participate in regular team meetings and provide input when appropriate

2. Other Activities:

Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries

Regularly reconcile the Safety database to the EDC database

Skills/Knowledge Required:

***Must have relevant and extended experience. Must be able to work with minimal supervision. Must be able to communicate well. Must have experience in managing data management deliverables end to end. Project and task driven.***

BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years of experience as a Data Manager in a pharmaceutical/CRO setting

Knowledge of Medical Affairs helpful

Experience in Hematology and/or Oncology

Proficient knowledge of EDC databases, preferably Medidata RAVE

Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers

Proficiency in regulatory guidelines, agencies, GCP

Knowledge of clinical trial process and data management process

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