CLINICAL DATA ENTRY/REVIEWER - MEDICAL DEVICES
: Job Details :

Job ID: 614783

Our client, a leading Medical Device company, is seeking an entry/junior level Clinical Data Reviewer. This role will be involved with entering, reviewing, modifying, reconciling, organizing data testing and verification of clinical data management systems. See below for other details!

***Please Note: This is a fully onsite role in Maple Grove, MN - please do not apply if you aren't able to work onsite***

Day to Day:

Reviewing, modifying, reconciling, and organizing data from assigned studies

Testing and verifying clinical data systems

Discrepancy management

Following FDA guidelines

Top Skills:

Attention to detail

Strong organizational skills

Effectively managing multiple projects

Great communication skills

Word, Excel, Outlook, Adobe

Summary/Things to Know:

• 100% Onsite Role will ensure integrity of study data by entering, reviewing, modifying, reconciling, and organizing data Testing and verification of clinical data management systems
• Discrepancy management (creating, routing, and resolving) Comply with FDA regulations
• Develop and maintain positive and trusting relationships with all levels of employees and customers
• Continuous Improvement mindset
• Will identify potential issues, this is very repetitive work
• Will require long periods of sitting or standing in the office
• Data will be studied and analyzed in Excel format so knowledge of pivot tables, search functions, and x-look-ups are required at an intermediate level

Job Duties:

With appropriate manager oversight, performs all data management activities for assigned studies

o Case Report Form (CRF) development and maintenance

o Edit Check specifications development and maintenance

o Data Management Plan development and maintenance

o Data Quality checks and discrepancy management

o Analyzes data, identifies trends; prepares data tables for clinical reports o Database setup testing and Edit Check programming testing

o External data handling

o Elements of device reconciliation

o Participate in Post Market Surveillance reporting as appropriate

Requirements:

• Education: Either High School Diploma or Entry Level College Graduate
• 0-1 years of experience - must be interested in data entry/review