Training Management

Kimberly A. Lubragge

*** ***** **** *****

West Chester, PA 19380

484-***-**** *.***********@*******.***

Experience: Synthes West

Chester, PA

*/****-*/**** ******** Systems Compliance Specialist

. Work with the business to develop software requirements,

validation protocols and test scripts

. Support company software validation projects and ensure Part

11 compliance of computer systems

. Work with business teams to develop verification and

validation testing plans

. Administration of the software tracking database and change

control management

. Maintenance and archival of all software validation

documentation

4/2009-5/2010 Clinical Data Coordinator

. Maintain all Clinical Data Associate II responsibilities

. CRF design, clinical trials protocol and documentation and

all related database validation activities

. Build, code, test and execute clinical trials within the

Electronic Data Capture (EDC) system

. Conducted all study related training for department

employees

8/2006-4/2009 Clinical Data Associate I & II

. Manage incoming and outgoing CRF workflow for six active

clinical trials

. Perform all CRF Tracking, 2nd data entry, scanning, merging

and filing of CRFs

. Assist with CRF creation, study documentation and database

validations

. Updated Adverse Event and Medication safety coding for all

clinical trials

7/2005-8/2006 HR, Quality Training Coordinator

. Support the Quality Training Manager with all Quality

document training determinations

. Schedule in house training sessions at multiple campus

locations

. Perform routine documentation audits to meet FDA and company

training requirements

. Assist in the creation of document training modules for

several e-Learning courses

Hudson Global Resources

Tampa, FL

2/2004-12/2004 HR, Training and Recruiting Associate

. Manage internal job posting process; 30 Day follow up calls

with new hires

. Project Management: organized a 10-week, 8-city, 250

employee training initiative

. Learning Management System: internal online employee

training; created training modules, distributed modules to

students, maintained the database and provided user

technical support

. Creation of training guides, training materials and

performance metrics for trainers and trainees.

Price Waterhouse Coopers, Inc.

Tampa, FL

12/2002-10/2003 HR, IT Recruiting Coordinator

. Worked on contract (Randstad), in the HR Department (IT

Recruiting) for a Big 4 accounting firm;

. Sourced IT candidates, leading to ten permanent hires,

saving PwC $16K+/per hire in outside vendor fees;

. Provided support to four recruiters: resume searches and

review, initial phone contact, scheduling interviews,

travel, job fairs and new hire orientation

Additional Experience: Various HR roles in Benefits, Compensation,

Relocation 2000-2002

Education: Immaculata University B.S., Health

Care Management

GPA 3.94 B.S., Human Performance

Management

Training: 2011 Quality Systems Training (QSM)

West Chester, PA

2010 Computer System and Software Validation

King of Prussia, PA

2009 Essentials of Project Management

Chicago, IL

2008 DIA, Good Clinical Practices for CRPs

Horsham, PA

OmniComm/EDC system training

West Chester, PA

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