Sector Experience
Healthcare
Life Sciences & Pharma
Fortune 500
Experience
DJP Consulting, LLC
Management Consulting
Independent Consultant
1/2019 - Present
-Conduct Contract GCP Compliance Audits for Clients including: Investigator Site, Central Vendors, Trial Master File, SOPs
-2019-2020 Client Audits were in: oncology, anti-infective and anti-inflammatory compounds
-2019-2020 Client Audits were in: oncology, anti-infective and anti-inflammatory compounds
PRA Health Sciences
Other
Senior Quality Auditor / Quality Planning
1/2015 - 12/2019
-Concentration on oncology drug classes: kinase inhibitors, antiandrogens, antineoplastic agents and monoclonal antibodies
Syneos Health
Other
Quality Governance / Principal Quality Auditor
2/2012 - 12/2014
-Assessed risk by trending key performance indicators and hosted periodic Quality Meetings for review of emergent risks.
-Conducted audits: investigator sites (both routine and for cause), laboratories, vendors, protocols, clinical study reports (CSRs), clinical data management (DM) and statistical review plans.
-Interpreted regulations and guidance documents governing GCPs and applied the interpretation to daily work for client teams and/or representatives.
-Conducted audits: investigator sites (both routine and for cause), laboratories, vendors, protocols, clinical study reports (CSRs), clinical data management (DM) and statistical review plans.
-Interpreted regulations and guidance documents governing GCPs and applied the interpretation to daily work for client teams and/or representatives.
Merck
Other
Clinical QA Manager
1/2003 - 12/2011
See resume for details.
Merck
Other
Senior Clinical QA Auditor
1/2001 - 12/2002
See resume for details.
Merck
Other
Clinical QA Auditor
1/1997 - 1/2001
See resume for details.
Merck
Other
Data Management Coordinator
5/1992 - 1/1997
See resume for details.