Job Description :
Title : Risk Management Data Analyst
Duration : 12 months
Location : Indianapolis, IN

Top Skills : Data Analysis

Duties:
The Risk Management Data Analyst will enter processed and summarized data for review.
The Risk Management Data Analyst will collect, analyze and process the data and compare results to previously gathered data for gap analysis; prepare a summary report and communicate results to risk management and Quality.
Proficiency in Microsoft Excel and Word as well as excellent written and verbal communications is required.
Minimum of 2 years of data analysis experience is required.
Laboratory systems or laboratory technician experience is a plus.
Responsible for developing an annual review schedule of all client products and performing the annual Periodic Risk Management Reviews for the various product Risk Management documents by collecting, analyzing, and reporting data including but not limited to GTC, CAPA, CM Clarify complaint data and Med Watch, ascertain any impact said data may have on the current product risk assessment levels of occurrence and severity of existing risks and identifying any new risks.
The data, any recommended changes to the Risk Management Document under review, and justification for those changes are then compiled into the periodic review report to be submitted for Quality for approval and then to Project Records Responsible for performing updates to existing Risk Management Documents as needed based on recommendations ascertained from the periodic review findings and obtain management approval as needed
Responsible for collecting, analyzing, and reporting data for product gap analyses as needed for current and new projects Manage and maintain ''Risk Tracker'' database by addressing newly identified risks in the applicable Risk Management Documents Responsible for maintaining departmental SOPs and related attachments.
Validate the Risk Management templates as required via software verification process.
This includes development as well as execution of test plan and protocol, report preparation, creation of verification statement, getting required approvals on all documents and processing all records for controlled storage in document repository.
Manage and process workflows, approvals, records keeping and other administrative tasks as needed for the Risk Management Team Assist Risk Management Team in updating Risk Management document, comparison of other product documents for consistency and gap analysis, recommend updates and coordinate management approval
Required Skills:
Excellent computer skill specifically in Microsoft Excel, Word and PowerPoint Analytical skill in data analysis
Technical Writing Excellent communication & Presentation - written and verbal Self-Organized
Experience with Data Analysis Laboratory Experience
Education:
College Degree in related field with minimum 2 years of data analysis experience is essential; Laboratory System or Laboratory Technician experience is a plus