
Clinical Research Contracts Manager at Quintiles, Inc.
Kansas City, Missouri Area

Clinical Research Contracts Manager at Quintiles, Inc.
Kansas City, Missouri Area
I spent eight years at Shook, Hardy & Bacon, representing the pharmaceutical industry in multi-million dollar products liability cases before moving to Quintiles' US Clinical Development Services Division in March 2008. As a Site Startup Specialist I negotiate contracts between physicians who are participating in clinical trials and the sponsors whose drugs/devices are being tested. I am also responsible for ensuring their regulatory documents are GCP/ICH/FDA compliant and are IRB-approved. As as a team lead I manage a group of specialists who perform these functions as well as provide guidance to other functional groups.
FDA and ex-US regulatory, pharmacovigilance, contract negotiation, document review, multi-district litigation, IRB
(Privately Held; Pharmaceuticals industry)
December 2009 — Present (1 month)
Manage contracts for Quintiles Phase I unit in Overland Park, KS.
(Privately Held; QTRN; Pharmaceuticals industry)
March 2008 — December 2009 (1 year 10 months)
Quintiles is the world's largest Clinical Research Organization. As part of the Site Start-Up (SSU) team I review and negotiate clinical trial site regulatory documents and contracts and prepare Independent Ethics Committees and Institutional Review Board submissions.
(Partnership; 1001-5000 employees; Law Practice industry)
January 2000 — January 2008 (8 years 1 month)
(Public Company; 5001-10,000 employees; FON; Telecommunications industry)
June 1999 — December 2000 (1 year 7 months)
Negotiate leases for sites on which to place telecom equipment.
(Privately Held; 1-10 employees; Law Practice industry)
August 1998 — June 1999 (11 months)
Represent debtors, creditors, and trustee in bankruptcy actions
JD , 1995 — 1998
Dean's List
BS , Pre-Law Justice Systems, Political Science, International Relations , 1990 — 1994
Bright Flight Scholar, Dean's List
Political consulting, international travel
Missouri Organization of Defense Lawyers, Missouri Bar, Republican National Lawyers Association, Young Republicans