Dianne Dalton
Seaside Park,NJ
Overview
24
24
years of professional experience
Work History
Inspection Readiness Consultant
Inspection Readiness Consulting, Inc.
03.2005 - Current
- Company Overview: Clients include Pharmaceutical and Biotechnology. Regulatory and Clinical Research Organizations. Focus is GxP Consulting, Inspection Readiness and Process Improvement for Phase 3 Global Clinical Trials utilizing the Bioresearch Monitoring Program (BIMO)
- Remote: (2019-present) Altimmune, Bioserenity, Aimmune, and Amylx
- Clients: Daiichi Sankyo, Intercept, La Jolla Pharmaceuticals, and InClin, Inc. (Rare Disease)
- Daiichi Sankyo (2015 - 2018): GCP auditor for phase III studies: Performs internal and external inspection readiness audits, to assure compliance with legal contracts, quality agreements, policies, procedures, global GCP regulations and guidelines
- Intercept Pharmaceuticals (2015-2018): GCP Quality Assurance Consultant for Inspection Readiness
- La Jolla Pharmaceutical Company (2015 2017): GCP Quality Assurance Consultant for Inspection Readiness
- InClin, Inc (2013-2015): Quality Assurance Inspection Readiness consultant for EMA and FDA audits
- Clients include Pharmaceutical and Biotechnology. Regulatory and Clinical Research Organizations. Focus is GxP Consulting, Inspection Readiness and Process Improvement for Phase 3 Global Clinical Trials utilizing the Bioresearch Monitoring Program (BIMO)
Clinical Program Manager
UNIVERSITY OF CALIFORNIA, San Diego
01.2012 - 01.2014
- Company Overview: Department of Neurosciences
- Provided leadership and direction for the ADCS Clinical Monitoring group which monitored multiple Phase II-III Alzheimer's Disease research trials at over 70 research sites throughout the United States, Canada, and Australia
- Department of Neurosciences
Consultant
BERG PHARMA
01.2011 - 01.2013
- Company Overview: (Oncology)
- Provided Project, Program, Safety Committee and Financial Management services for this biotech company during a Phase I Pancreatic Oncology Trial. Monitored 2 clinical trial sites for GXP compliance.
- (Oncology)
Consultant
NANOGEN
01.2011 - 01.2013
- Company Overview: (Medical Diagnostics (Cardiovascular Device))
- Advised key decision makers on process improvement.
- High level presentations included financial analysis, case studies and process strategies.
- Implemented process improvement and training in emergency departments.
- Reported all key data points for clinical trial.
- (Medical Diagnostics (Cardiovascular Device))
Consultant
MEMGEN
01.2011 - 01.2012
- Monitored a Phase I trial at University of California, San Diego Cancer Center for compliance, GXP and Safety.
Clinical Operations Manager-Global
PFIZER
01.2006 - 01.2011
- Managed multiple domestic and international clinical trial budgets.
- Directed performance management of 14 Regional Site Managers.
- Interviewed, hired and trained all direct reports.
- Worked on the Torcetrapib/Atorvastatin Cardiovascular trials from study start-up through close out of all sites. Managed all legal issues through Pfizer.
- Made strategic and tactical decisions for monitoring/study management activities.
- Provided site and clinical investigator selection information to the therapeutic area project specialists.
- Managed and coordinated operational aspects of clinical trial support within and across therapeutic groups.
- Responsibilities included submitting high quality data and ensuring monitoring standards were in compliance with ICH/GXP and Pfizer SOP requirements.
- Provided leadership to promote harmonization for standard working practices with a focus on increasing efficiencies.
- Lead on the Infectious Disease audit team.
- Worked primarily on Oncology, CNS, Cardiology, and HIV studies.
Clinical Research Site Manager
PFIZER
01.2006 - 01.2011
- Monitored Phase I-IV Cardiovascular Trials.
- Acted as Lead Clinical Research Site Manager for two protocols to include protocol training, process training and data distribution and collection. Met all deadlines given by project team.
- Evaluated the monitoring plan throughout the conduct of a clinical study and revised as needed.
- Managed data discrepancies for the entire study and coordinated the clinical monitoring activities to ensure that these discrepancies are resolved in the established timeframe for resolution.
- Managed current product inventory throughout clinical study (retention samples for QA; laboratory studies product; clinical study product). Revises the clinical product inventory needs as indicated and communicates the revision to the Clinical Project Team.
- Monitored study sites using reduced source documentation tools and electronic data capture Utilized MS Project to manage various studies.
Clinical Research Associate II-International Studies
BIOMARIN
01.2002 - 01.2004
- Company Overview: (Rare Disease)
- Data Management for International Pediatric studies ranging from Phase II through Phase IV.
- Managed a CRO who monitored sites in England, Italy, Germany, France, and Brazil.
- Managed a budget for each country involved in this study.
- Managed shipping and receiving of laboratory samples internationally.
- Managed regulatory inventory for five different countries.
- (Rare Disease)
Education
Bachelor of Science - Biological Sciences
Trinity College
Burlington, VT06-1996
Master of Arts - Public Administration
University of San Francisco
San Francisco, CA05-1993
Bachelor of Arts - Accounting And Finance
East Carolina University
Greenville, NC06-1987
Skills
Technical review
Accomplishments
Consulted on 10 FDA and 8 EMA inspections. All were successful and moved to the next stage of development.
Timeline
Clinical Program Manager
UNIVERSITY OF CALIFORNIA, San Diego
01.2012 - 01.2014
Consultant
BERG PHARMA
01.2011 - 01.2013
Consultant
NANOGEN
01.2011 - 01.2013
Consultant
MEMGEN
01.2011 - 01.2012
Clinical Operations Manager-Global
PFIZER
01.2006 - 01.2011
Clinical Research Site Manager
PFIZER
01.2006 - 01.2011
Inspection Readiness Consultant
Inspection Readiness Consulting, Inc.
03.2005 - Current
Clinical Research Associate II-International Studies
BIOMARIN
01.2002 - 01.2004
Bachelor of Science - Biological Sciences
Trinity College
Master of Arts - Public Administration
University of San Francisco
Bachelor of Arts - Accounting And Finance
East Carolina University
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