Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
EXPERIENCE
Consultant, Sept 2003 - Present
* Clients - CliniQual, RX Solutions, ROX Medical, Inc.
Sr. Director, Clinical Affairs, ROX Medical, San Clemente, CA Sept 2009- Octob
er 2010
* Report to Vice President of CA/RA/QA
* Plan, author, direct and/or execute multiple concurrent clinical studies
* One IDE pilot clinical trial for class III medical device (US)
- ICR/Fax Data Management System
* One OUS pivotal trial for class III medical device (EU)
- Internally developed and validated ACCESS database
* One Post-market study/registry for CE Marked class III medical device (EU)
- Combination of paper & EDC
* Provide strategic direction, management and development of the clinical staff
(Data Management, In-house CRAs, Field CRAs, Clinical Safety, Interns, Project C
oordinators, Consultants, Contractors)
* Perform product training and support cases in the field
* Subject Recruitment Strategy identification & implementation (incl. local IRBs
for site level recruitment, WIRB for study level recruitment campaigns, interne
t advertising, website SEO, SEO, call centers, patient support group collaborati
ons & presentations)
* Resource modeling for right balance of clinical staff (functionally & in-sourc
e v. outsource) during study phases
* Efficacy data review and analysis
* Safety data review, narrative writing and analysis
* Develop and maintain multi-million dollar budgets
* Vendor management (core labs, data management, translations)
* Develop & update departmental processes & SOPs, flowcharting
* Implemented quantitative goals, metrics and dashboards to bring transparency t
o the activities in Clinical Operations to Executive staff and Board of Director
s
* Quarterly presentations to Board of Directors
Director, Global Clinical Operations, Medtronic CardioVascular, Santa Rosa, CA
June 2005- Sept 2009
* Report to Vice President of Global Clinical Affairs in support of Coronary Vas
cular, Peripheral Vascular and Endovascular therapies.
* Provide strategic direction, management and development of the clinical operat
ions departments and it's employees (Clinical Payments, Clinical Contracts, Alli
ance Management, Field Operations, Clinical Safety, Clinical Quality, Clinical L
earning & Development and Clinical Systems)
* Develop internal processes to streamline department activities including imple
menting and/or developing software, communication centers, intranets, databases
* Developed capacity models for clin ops departments for determining required re
sources and mix of insourcing and outsourcing to support on-going and proposed s
tudies
* Develop and maintain multi-million dollar budgets
* Implemented EDC / CDMS and currently implementing a CTMS software solution for
CV Clinical Affairs globally
* Implemented CFR Part 11 compliant safety system (Oracle AERS)
* Wrote DOPs describing internal and external clinical research activities
* Implemented quantitative goals, metrics and dashboards to bring transparency t
o the activities in Clinical Operations to strategic partners
Wrote and Defended Thesis, Kettering University, Michigan, January 1999 - March
2000
Mechanical Engineer & Documentation Services Manager, Aetrium Inc., San Diego, C
A
April 1997- Dec. 1998
* Develop assembly guides, procedures, and engineering drawings
* Determine manufacturing costs, time standards, tooling and processing requirem
ents, cause of rejected parts and disposition
* Determine maximum utilization of production facilities and personnel
* Provide cost studies and equipment recommendations
* Target potential failures and fatigue problems
* Manage the activities of Documentation Services personnel
* Developed a semiconductor contactor to measure temperature which resulted in a
n increase in accuracy from 74% to 99.2% -time of product in final test went fro
m 8 to 1 hours
Mechanical Engineer Intern, Guidant (formerly EVT), Menlo Park, CA July 1995 -
Sept. 1996
* Statistical data analysis
* Perform failure analysis and implement manufacturing modifications to increase
product yield
* Material Review Board lead, production trainer, process validation
* Designed renal artery markerboard used during AAA endovascular surgery
* Developed surgical procedure for Ancure AAA catheter deployed graft.
PRESENTATIONS / PUBLICATIONS
Collaboration with Michael Argenziano, M.D., Columbia Presbyterian Medical Cente
r, New York, NY, on Laser Technology for Atrial Fibrillation Ablation presentati
on at the Third Annual Conference on the Surgical Treatment of Atrial Fibrillati
on in San Francisco, CA, hosted by Ralph Damiano, M.D., June 18th 2003.
Conner, A., Canton, G., Lasheras, PhD, J., Levy, MD, D., "Comparative Measuremen
t of the Hemodynamic Stresses in Embolized and Non-embolized A-Com Aneurysms: Ne
ck Remnant Effect", to be published in neuroradiology/ surgery journal, and pres
ented at industry conference.
Conner, A., "Onyx Delivery Techniques", Thesis under Professor M. Tavakoli. Anal
ysis of Micro Therapeutics, Inc Onyx liquid embolic for the treatment of arterio
venous malformations. Portions presented at WIN/ABC, January 2001, Val d'Isere,
France.
Conner, A., "Less Invasive Approach to Treating AAA". Under cooperation with Gui
dant Cardio & Vascular Surgery Group, presented to new Kettering University Medi
cal Device Design specialty students as introduction to industry, 2000.
PATENTS
Patent 7,018,365, "Threaded Syringe with Quick Stop"
Patent 7,374,568: "Methods for Embolizing Aneurysms with a High Viscosity Emboli
zing Composition"
Patent 6,527,732: "Torsionally Compensated Guidewire"
CERTIFICATIONS
Operating Room Protocol for the Healthcare Representative; Sponsored by HealthSt
ream - Recognized by AORN.
Exposure to Bloodborne Pathogens in the Surgical Environment; Sponsored by Healt
hStream.
Certified Clinical Research Associate (CCRA) by Association of Clinical Research
Professionals (ACRP), 2003.
Medtronic Director Development Program, Wharton, University of Pennsylvania, Dec
2007-May 2008.
EDUCATION
CALIFORNIA STATE UNIVERSITY, FULLERTON Irvine, CA
Master of Business Administration (MBA), 2003
KETTERING UNIVERSITY (formerly GMI) Flint, MI
Bachelor of Science, Mechanical Engineering (BSME), Thesis Defended, 2000.
Biomedical specialty.
OTHER SKILLS
* Experienced with FDA/ISO/QSR standards for Design Control/Project Planning, St
atistical Analysis, Risk Analysis, DOE
* Advanced AutoCAD skills
* Advanced FMEA skills (software: IDEAS)
* Intermediate Solidworks 2000 skills
* Basic Pro-E skills
* Programming Languages: C++, FORTRAN
* Engineering Software: LABView, MATLAB, Simulink
* Proficient with MS Office tools (MS Word/Excel/Access/Project/PowerPoint)
* Proficient with MAC iLife tools
* Proficient in web design including intranet solutions (i.e., SharePoint)