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 Posted: Tue Jul 03, 2007 10:24 pm Post subject: US-MA-Marlborough: Senior Clinical Data Manager |
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http://biotech.fyicenter.com/jobs/99896354_Senior_Clinical_Data_Manager.html
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Date: 03-Jul-2007
Senior Clinical Data Manager
Responsibilities
This individual will oversee data management functions for clinical
studies across multiple drug programs outsourced to CROs or performed
internally. Specifically, you will review study protocols, develop
CRFs and CRF Completion Guidelines, maintain Data Management Plans,
oversee project timelines, participate in the validation of the
Clinical Data Management System (CDMS) and related systems using
Oracle Clinical, and provide status reports to appropriate teams. You
will also be responsible for medical coding functions, supervision of
contracted resources, and review of bids, exhibits and contracts.
Experience required 7 - 10 Years
Experience and other requirements
Requires a Bachelor's degree in a biological or health-related field,
6-10 years of related experience in a life sciences discipline,
including 4 years in clinical data management in the pharmaceutical,
biotech, or CRO industry, and solid project management skills.
Applicants must have extensive knowledge of relational databases, and
dictionary coding, quality coding, quality control, and auditing
procedures. Must be familiar with GCP, ICH, and FDA regulatory
requirements as they apply to clinical data management. Oracle
Clinical and/or SAS experience is
Thank you,
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