Sector Experience
Healthcare
Life Sciences & Pharma
32
years
Years of Experience
6/20
Member Since
Fortune 500
Experience
DJP Consulting, LLC
Management Consulting
Independent Consultant
-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
-Concentration on oncology drug classes: kinase inhibitors, antiandrogens, antineoplastic agents and monoclonal antibodies
Syneos Health
Other
Quality Governance / Principal Quality Auditor
-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
See resume for details.
Merck
Other
Senior Clinical QA Auditor
See resume for details.
Merck
Other
Clinical QA Auditor
See resume for details.
Merck
Other
Data Management Coordinator
See resume for details.