Customer Service Sales

Michael Bailey, MBA

Medical Writing Quality Control Reviewer at Advanced Clinical Research Services

***********@*****.***

Summary

Professional Skills:

•Enthusiastic team player and proven leader

•Exceptional oral and written communication skills

•Thorough, highly-organized individual who pays close attention to detail

•Ability to react to constantly changing environments and timelines

•Analytical, inquisitive and intelligent

•Experienced in cross-functional team settings to accomplish project-specific goals

•Basic Project Management skills including budgeting, risk analysis, contingency planning and work-flow

diagramming

•Self-motivated, quick learner, customer-friendly, multi-tasker who enjoys new challenges

•Microsoft Project experience and proficient in the following programs: Microsoft Word 2007 and 2010, Excel

2007 and 2010, Power Point 2007 and 2010, Outlook 2007 and 2010, Adobe Acrobat

•Ability to quickly utilize new software systems and procedures

•A genuine interest in obtaining knowledge and educating individuals

•Adapts quickly to rapidly changing environments

Specialties: 21 cfr part 11, customer service, documentation, editing, project planning, retail sales, sales,

software documentation, validation, UAT and Validation script writing, proficient in the following programs:

Microsoft Word 2003 and 2007, Excel 2003 and 2007, Power Point 2003 and 2007, Outlook 2003 and 2007,

Adobe Acrobat

Experience

Medical Writing Quality Control Reviewer at Advanced Clinical Research Services

September 2011 - Present (1 year 10 months)

Assisted in the writing and preparation of publications, clinical, and regulatory documents/submissions

Performed detailed quality review of clinical and regulatory documents as well as SAS data listings and

analyses

Developed and reviewed SOPs, clinical document formats and guidelines including the corporate style guide

Collaborated with a team to ensure that clinical data issues are addressed and resolved

Assisted in the planning of timelines for document formulation and review

Edited presentations and created sales sheets for marketing activities

Clinical Data Operator at Advanced Clinical Research Services

November 2010 - September 2011 (11 months)

Reviewed Case Report Forms for clarity and correctness

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Entered raw trial data into Oracle Clinical as it was received from investigators

Worked as a team to resolve any discrepancies in data and develop new guidelines for data entry

Exceeded company expectations for data entry and error rates

Performed company-wide quality checks on processes and recommended system changes for flow of

information to relieve work stoppage

Business and Software Requirements Analyst at CompleWare Corporation

February 2008 - October 2009 (1 year 9 months)

Maintained software documentation for proprietary software developed by the Company

Assembled information regarding software changes for upcoming releases of existing software

Created and maintained documentation such as Traceability Matrices, Requirements Specifications, Project

Plans and Software Validation Tests to meet FDA standards, primarily 21CFR part 11.

Analyzed study documentation to aid in the creation of stress tests for study-specific software.

Extensive work with efficiency analysis of current and past procedures regarding the implementation of new

software version releases.

Assisted in the training of new employees within the IT department

Data Analyst at CompleWare Corporation

February 2006 - February 2008 (2 years 1 month)

Collaborated with cross-functional teams to organize study closeout procedures to meet constantly moving

timelines

Utilized proprietary software in the analysis of study metrics collected for clinical trials

Organized documentation regarding the approval for editing and correction of clinical data to meet Sponsor

requirements.

Assisted in the training of new employees within the IT department

Lead Bookseller at Barnes & Noble Booksellers

December 2004 - February 2006 (1 year 3 months)

Organized a fluctuating area of books as well as maintained and set up new displays

Ordered quantities of new and existing products to meet and exceed current sales goals

Actively participated in training new hires in corporate policy, function, expectations and requirements within

the retail sales environment

Allocated part-time booksellers to positions that would maximize their output

Responded to a wide variety of customer service issues and concerns in quick succession.

Computer Sales Lead at Best Buy

December 1998 - August 2003 (4 years 9 months)

•Assisted a diverse customer base in choosing the right product and accessories for their needs in various

departments while maintaining company ideals and exceeding sales goals

•Assisted in planning of product placement to maximize exposure

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Skills & Expertise

Microsoft Excel

Software Documentation

Leadership

Project Management

MS Project

Analysis

Outlook

Project Planning

PowerPoint

Customer Service

Marketing

Cross-functional Team Leadership

Strategic Planning

Microsoft Word

Sales

Microsoft Office

Testing

Data Analysis

Software

Data Management

Clinical Research

Education

Robert Morris University

Master of Business Administration (MBA), Business Administration, Management and Operations, 2010 - 2012

Mount Mercy College

Bachelors of Business Administration, Marketing, 2009

1 recommendation available upon request

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Michael Bailey, MBA

Medical Writing Quality Control Reviewer at Advanced Clinical Research Services

***********@*****.***

1 person has recommended Michael

"Michael demonstrated a keen sense for the balance of "big picture" and the appropriate details while

understanding the strategic direction of an organization is his competitive advantage. His ability to be an

analytical thinker coupled with asking the right questions makes him a true value to any team. Michael

understands his contribution and can truly articulate it in most any situation. He is a great team player and

knows the roles that exist in shared goals. Any employer would appreciate his strong work ethic!"

Robert M. Tenuta, MBA, MSMOB, Faculty (Graduate / Undergraduate), Robert Morris University of

Illinois (RMUI), taught Michael at Mount Mercy College

Contact Michael on LinkedIn

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Contact this candidate