1. RICHARD MICHAEL WILLOUGHBY
7604 5th Ave upper
Kenosha, WI 53143
262-705-1549
auxaous@yahoo.com
SUMMARY: Hello, I am a business oriented professional with 15+ years in the
Pharmaceutical and Healthcare industry. I possess strong organizational and verbal
skills, analytical expertise, and interpersonal skills. I am detail oriented with an aptitude
for multi-task operations and have an ability to work independently with minimum
direction and/or within a group setting. Experience in the use of Arisg Safety databases,
and Oracle Clinical/EDC databases on many different clinical drug and medical device
studies, for many different companies/projects. I have experience in data management,
Pharmacovigilance and PV technology. Medical terminology is a strength. Hospital/ICU
experience. Experience working under strict deadlines.
SKILLS: Experience working in Global Safety/GPV, Adverse Event case processing and
narrative writing, ARISg, Oracle Clinical, EDC, RDC, IMedNet, AEGIS, MEDRA,
Windows/MS Office: Word, Excel, Outlook, Sharepoint. Oversaw/ran the scheduled
reporting area on the GPV team/data management team. Made assignments and
calendar, responsible for over 100+ reports (weekly, monthly, quarterly, etc). I helped
successfully lead the transition project of data management scheduled reporting area to
an outsourcing company.
Professional Job Experience
Baxter Healthcare Corporation 2013- Present
Deerfield, IL
Safety Data Analyst
 Oversees/monitors outsourced scheduled reporting area in data management GPV
 Generate complete and accurate periodic reports and ad-hoc reports
 Standardize queries to ensure consistency ofreports generated
 Collaborate with the report requester to assure accurate interpretation of the data request
 Ensure timely completion and distribution of regulatory reports and query requests
 Serve as a data integrity escalation contact for downstreamusers of Pharmacovigilance data (Safety
Writers, Medical Reviewers, Risk Management, Epidemiology, etc.)
 Ensure consistent interpretation of systemrelated conventions,specifications,and definitions between
GIT and GPV functional areas
 Ensure consistent interpretation of systemrelated conventions,specifications,and definitions between
GIT and GPV functional areas
 Take initiative to recognize, prioritize & escalate potential safety/ compliance issues
 Identify and troubleshoot root causes of thematic data integrity issues

2. RICHARD MICHAEL WILLOUGHBY
7604 5th Ave upper
Kenosha, WI 53143
262-705-1549
auxaous@yahoo.com
 Identify potential errors and omitted data found during query and address them for review to the
responsible user
 Participate in the development of system-related training programs in support of data integrity
initiatives
 Other functions within Pharmacovigilance in all aspects ofdata management
Advanced Clinical Aug 2010-Mar 2013; Deerfield, IL
Clinical Data Management Associate
 Follow Standard Operating Procedures (SOP’s), Data Processing Plans (DPP’s) and client conventions
to perform first and second pass entry
 Perform DCF entry
 Provide feedback using the error tracking systemand verbal/visual communication to personnel
performing entry
 Perform QC checks using applicable browser tools
 Aiding in Study Set-up (User Acceptance Testing on the database and on edit checks)
 Assist with DM review (Manual review verifying edit checks in the DMRP are working properly.
Identifying data discrepancies outside of the DMRP and creating manual queries where necessary
 Provide feedback and communicate potential issues to Clinical Data Managers (CDM’s) and Project
Leads on study-related discrepancies and issues
 Review PageTrack reports for accuracy and consistency
 Assist in the maintenance of the Data Management Plan (DMP)
 Assist with Final QC Reviews and data listing audits
 Assist the CDM or Senior CDM with maintaining/compiling all study documentation
 Tracking and filing
 Prepare CRFs for data entry (set-up)
 Participate in client meetings when applicable
 Assist in the creation and reviewing of SOPs and training manuals
 Ad hoc report writing
 Database Testing
 Assist in training employees
 Perform other duties as requested by management

3. RICHARD MICHAEL WILLOUGHBY
7604 5th Ave upper
Kenosha, WI 53143
262-705-1549
auxaous@yahoo.com
Senior Clinical Data Operator
 Follow Standard Operating Procedures (SOP’s), Data Processing Plans (DPP’s) and client conventions
to perform first and second pass entry on CRFs
 Inform Clinical Data Managers (CDMs) of any study-related discrepencies/issues including
feedback on the DMP for the study
 Provide feedback using the error tracking systemand verbal/visual communication to personnel
performing entry
 Use error reports as feedback to improve entry performance
 Prepare CRFs for data entry (set-up)
 Perform Data Clarification Form (DCF) entry (1st and 2nd pass)
 Perform QC checks using the applicable browser tools
 Learn how to utilize the DMRP
 Create and enter test data for User Acceptance Testing on the database prior to activation and
provide feedback to the CDM
 Assist with Final QC Reviews
 Provide data entry training for new employees
Clinical Data Operator
 Follow Standard Operating Procedures (SOP’s), Data Processing Plans (DPP’s) and client conventions
to perform first and second pass entry on CRFs
 Inform Clinical Data Managers (CDMs) of any study-related discrepencies/issues including
feedback on the DMP for the study
 Provide feedback using the error tracking systemand verbal/visual communication to personnel
performing entry
 Use error reports as feedback to improve entry performance
 Prepare CRFs for data entry (set-up)
 Perform QC checks using the applicable browser tools
 Learn how to utilize the DMRP
Manpower (Contracted to Abbott Laboratories) Aug 2008-May 2010 Waukegan, Il
Information Specialist II (Safety/Pharmacovigilance)
 Proficiency in use of the AEGIS Database
 Casing processing for AEs (adverse drug events (in both post-marketing and clinical settings)
 Operation according to specific deadlines
 Narrative and medical history writing , use of medical terminology, coding of drugs and medications

4. RICHARD MICHAEL WILLOUGHBY
7604 5th Ave upper
Kenosha, WI 53143
262-705-1549
auxaous@yahoo.com
Vista Health/Vista East Hospital Aug 1998-Aug 2008 Waukegan,IL
ICU Unit Secretary/Monitor Tech
 Monitoring/reporting of patients life-signs/vitals in the Intensive Care Unit
 Data entry and transcription of physicians /nurses orders
 Providing support for daily operations in the ICU. Construction and maintenance of patient charts and
other medical records
 Answering phones/Greeting visitors
 Scheduling appointments, tests and transportation
Skills
 ARISg, Oracle Clinical Database, EDC databases,Windows/MSOffice: Word, Excel, Outlook
 Medical terminology background,familiar with disease/condition names, treatments, drug names, etc.
 Experience working in Safety/GPV databases
 Experience querying/discrepancy management on drug and medical device studies
 Skills working understrict deadlines
 Excellent auditing/QC skills
 Adverse event case processing/narrative writing
 Some medical coding experience
 Creative writing and editing skills
 Computer and data entry skills
 Excellent coffee-making skills
 Detail oriented/keen observationalskills
Education
University of Wisconsin-Parkside Kenosha,WI
Graduated 2004/BA English