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Clinical Data Manager at Millenniumsoft INC in San Jose, CA

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Position: Clinical Data Manager
Location: San Jose CA 95131 UNITED STATES
Duration: 6+ Months Contract

Qualifications:
• Bachelor’s degree in related field with min 3 yrs. experience in clinical data management.
• Equivalent education or experience will be considered.
• Experience min 3 yrs. in regulatory submission of medical devises; - Use of relational databases

Responsibilities:
JOB SUMMARY:
Perform all aspects of data management tasks from clinical trial preparation to close-out of study utilizing paper and/or electronic format.
Sound clinical data management judgment must be exercised within broadly defined regulations and internal procedures to achieve high quality and accurate clinical data.
Provide necessary training to clinical associates.

RESPONSIBILITIES: * Guides teams on data capture methods (egs. Electronic data capture (EDC), paper, handheld)
* Case Report Form design, including the development of requirements, specifications, designs, annotations, and training materials for CRFs, utilizing paper and electronic formats.
* Provides written specifications and procedures for loading non-CRF data into the database in collaboration with data analysts.
* For EDC, ensures that user acceptance testing is completed prior to implementation and deployment to clinical trial sites. Ensures that the requirements for data transfers and integration

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