Project Manager Operations
Resume:
JEFFREY D. AZZALINA
Honolulu, HI
*******.********@*****.***
SENIOR CLINICAL TRIAL OPERATIONS MANAGER
Accomplished senior clinical research scientist / project manager. Over twenty years of diverse experience in clinical investigations and research and development. Facilitated approximately ten new drug and OTC approvals through the FDA.
Oncology
Respiratory
Budgeting
Diabetes
Cardiology
Global Program Management
Central Nervous System
Infectious Disease
Site Monitoring
Internal Medicine
Phase I - IV
NIH Grants
CORE ACCOMPLISHMENTS
Senior Clinical Trial Operations Manager for Worldwide Diabetes Trial Operations Group
Senior International Clinical Trial Manager for Phase III SIADH studies
Presenter - Domestic and International Investigator Meetings, Scientific Meetings, and Symposia
Assisted in the Preparation of Clinical NDAs and INDs
Senior Project Manager for Multiple Clinical Imaging Studies
Analysis and Formulation of Peptide and Monoclonal Antibody Preparations
Design and Implementation of Clinical Protocols and Case Report Forms
Preparation of Regulatory Documentation and Study Budgeting
Methods Development and Validation of Analytical Testing Methods
Process Development and Scale-up
Supervision of Tissue Culture Laboratory
Management of Molecular Biology Laboratory
PROFESSIONAL EXPERIENCE
SANOFI
International Clinical Trial Management (2003 – 2017)
Global Clinical Program Manager
Senior Clinical Trial Manager
Senior Clinical Trial Operations Manager
Senior Clinical Trial Operations Manager for Worldwide Diabetes Trial Operations Group
International Clinical Trial Manager in Worldwide Diabetes Trial Operations Group
International Clinical Trial Manager for IL-6 Phase II program
Senior International Clinical Trial Manager for SIADH Phase III program
Global Clinical Program Manager for Infectious Disease group
Global Clinical Program Manager for Thrombosis group
Direct management of International Clinical Trial Managers
Responsible for all aspects of global trial management/strategic planning
Coordination and preparation of project timelines
Supervision/management of project status and clinical program team
JEFFREY D. AZZALINA
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PFIZER (formerly Pharmacia)
Endocrine Care, Outcomes Research
Project Manager (1998 – 2003)
Project Manager for Phase IV adult Growth Hormone deficiency trial
Project Manager for sub-studies within Phase IV program
Responsible for all aspects of trial management/strategic planning
Responsible for management of study personnel (four direct reports)
Responsible for oversight of study scientific advisory board
Responsible for software development and review
Responsible for the training of study sites, clinical team, marketing group and sales consultants.
Part of clinical/sales/marketing Endocrine Care Management Team
Attended numerous continuing education programs including an AMA Fundamentals of Marketing training course
BIO-IMAGING TECHNOLOGIES, INC
Senior Project Manager (1997 – 1998)
Responsible for all aspects of managing sponsor selected clinical imaging trials
Coordination and preparation of project timelines
Supervision of project status
Preparation of client status reports and blinded reading methodology reports for FDA submission
Assisted sales and marketing in new client development
BRACCO DIAGNOSTICS
CLINICAL DEVELOPMENT
Clinical Program Manager (1996 – 1997)
Responsible for all aspects of clinical studies management
Clinical Program Manager for MR imaging study of CNS lesions
Clinical Program Manager for liver cirrhosis MR imaging study
Management of clinical research organization
Preparation of study budgets - vendors and investigators
Design of protocols/amendments and case report forms
Preparation of documentation required for filing of studies at the FDA
FOREST LABORATORIES
MEDICAL DEPARTMENT
Senior Clinical Research Associate (1995 – 1996)
Clinical Research Associate (1993 – 1995)
Senior CRA for Alzheimer's disease study
Identification and evaluation of potential investigators and clinical sites
Initiation of phase II/III clinical studies
Assisted in the organization of investigator meetings
Assisted in the preparation of clinical NDAs and INDs
Assisted in preparation of protocol amendments and status reports
Review of clinical data and source documentation for clinical and regulatory compliance
Quality Assurance audits of clinical investigational sites
JEFFREY D. AZZALINA
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CYTOGEN CORPORATION
CLINICAL INVESTIGATIONS
Clinical Research Associate (1992-1993)
Senior Research Associate (1990-1992)
Identification and evaluation of potential investigators/clinical sites
Initiation of phase I, II, and III Oncology clinical studies
Assisted in the organization of investigator meetings
Assisted project leader and medical director in the preparation of protocol amendments and status reports
Reviewed clinical data and source documentation for clinical and regulatory compliance
Responsible for the implementation and monitoring of all quality control, stability, and radiochemical procedures performed on peptides and antibody conjugates
Validation and troubleshooting of clinical sites and analytical procedures
Provided in-service radioisotope training
Reverse phase, ion-exchange, and size exclusion chromatography
Radioimmunoassay development
Performed and documented clinical IND studies
EDUCATION
Ph.D. Candidate, Physiology/Biochemistry, Medical College of Pennsylvania, Philadelphia, PA
M.S., Biology, East Stroudsburg University, East Stroudsburg, PA
B.A., Biology, Lafayette College, Easton, PA
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