Nicole Kelley

abgw6t@r.postjobfree.com

314-***-****

Experience:

March 2010- Present Biomedical Systems - St.

Louis, MO

Pulmonary Services Clinical Project Manager

. Coordinate and manage centralized diagnostic services in global

Phase I - IV clinical trials requiring pulmonary services.

. Fully executed 4 contracts with the combined contract totals over 6

million dollars.

. Assist internal sales teams on obtaining new contracts and clients.

. Conduct bid defense meetings with new study teams to obtain new

clients and studies.

. Assist internal marketing teams in developing marketing materials,

training materials and training videos.

. Serve as primary contact for clients, regarding centralized diagnostic

services.

. Monitor projects from study start-up through delivery of final

electronic submission.

. Interact with internal and external project teams to assure

comprehensive management of projects.

. Conduct extensive equipment presentations and trainings to clients

and study participants.

. Presented at over 100 meetings for between 50-600 participants.

. Hold an extensive knowledge of a large variety of pulmonary

devices. Specifically equipment used for pulmonary function

testing.

. Organize the internal project activities to ensure the completion

of the project is on schedule.

. Coordinate and communicate project activities; produce metric

reports; conduct internal project status meetings.

. Capable of handling multiple responsibilities and projects on a

continuous basis.

. Trained to manage studies utilizing various software systems used

for pulmonary testing.

. Receive continuous training of internal SOPs, pertinent industry

information and industry regulations, including an annual training

of Good Clinical Practices and working knowledge of the E14

Guidance document.

November 2007 - Present Biomedical Systems - St.

Louis, MO

Cardiac Services Clinical Project Manager

. Coordinate and manage centralized diagnostic services in over 30

multi-national Phase I - IV clinical trials.

. Serve as primary contact for clients, regarding centralized

diagnostic services.

. Monitor projects from study start-up through delivery of final

electronic submission.

. Interact with internal and external project teams to assure

comprehensive management of projects.

. Conduct extensive equipment presentations and trainings to clients

and study participants.

. Hold an extensive knowledge of a large variety of cardiac devices.

Specifically equipment used for electrocardiograms, holter

recordings and cardiac stress testing.

. Assist internal sales teams on obtaining new contracts and clients.

. Assist internal marketing teams in developing marketing materials,

training materials and training videos.

. Organize the internal project activities to ensure the completion

of the project is on schedule.

. Coordinate and communicate project activities; produce metric

reports; conduct internal project status meetings.

. Capable of handling multiple responsibilities and projects on a

continuous basis.

. Trained to manage studies utilizing various software systems

compatible with GE and Mortara cardiac devices.

. Receive continuous training of internal SOPs, pertinent industry

information and industry regulations, including an annual training

of Good Clinical Practices and working knowledge of the E14

Guidance document.

September 2007 - November 2008 Rockwood

School District

Assistant Cross-Country Coach

. Assist Head Coach's prior to the season with setting up the workout

schedules and logistics of the upcoming season.

. Assist Head Coach's in everyday practice from setting up workouts,

putting the athletes through workouts and working with the student

athletes.

. Setting up the logistics of weekend meets and assisting the student

athletes and Head Coaches throughout the meet.

. Coving the responsibilities of the Head Coach's when they are not

able to attend meets or practices.

February 2007 - November 2007

Vi-Jon Laboratories - St. Louis, MO

Quality Control Analyst III

. Performing laboratory analysis on incoming raw materials, in-

process samples, and finished products per established procedures

by wet chemistry including HPLC and GC.

. Prepared samples for chromatographic analysis and performed

extensive micro testing of all raw materials and products.

. Coordinated information between the laboratory and internal

customers to ensure quality products.

. Worked with minimal supervision, and provided training,

direction and information to analysts I & II.

Summer 2006, 2005, 2003 Covidien

Healthcare / Mallinckrodt - St. Louis, MO

Summer 2006 Intern

. Assisted with FMOC solid phase peptide synthesis in the division of

peptide research and development. Worked individually with each

step in synthesis process from reactor set-up to cleavage,

purification and lyophilization.

. Worked with the analytical department assisting with high

performance liquid chromatography and thin layer chromatography of

final products.

. Viewed bulk production process of Leuprolide.

Summer 2005 Intern

. Assisted with document analysis and updated manufacturing division

batch records to comply with company codes and cGMP.

. Reviewed and corrected all vendor approvals for FDA inspections.

. Reviewed non-standard logs to ensure items had been properly closed

out and corrected files.

. Designed cover of employee handbook for quality division.

Summer 2003 Intern

. Created an online directory of library resources.

. Re-organized library resources to accommodate a five-year growth.

. Worked with colleagues from all divisions to assist with research

and retrieve journal articles.

. Cataloged incoming journals.

Education: University of Missouri - Columbia

. B.S. in Biochemistry with a focus in Economics and

Chemistry

Honors:

University of Marquette

. Member of the NCAA division I, cross-country, indoor track and field

and outdoor track and field teams.

. 2000-2002 Conference USA academic honor teams.

University of Missouri

. Member of the NCAA division I, cross-country, indoor track and field

and outdoor track and field teams.

. 2002-2006 academic All-Big 12.

. 2006 All-Big 12 athlete.

. 2005 Marvin Patterson Award for excellence by a student-athlete.

. University of Missouri 2002-2006 Dean's List.

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