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Asican Rozar
7012 Winchell
Road, # 9
San Jose 40141
Phone: (362)
487-3024
Email: asican_rozar11@gmail.com
SUMMARY
- Over 20 years clinical research
experience in the US, Canada, and Europe (including 17 years in phase I-IV
clinical trials).
- SAS Programming and Clinical Data
Management experience in the pharmaceutical, biotech, and device
industries.
- Extensive experience with the complete
clinical research process (from protocol development to regulatory
submission).
- Strong knowledge of ICH/GCP guidelines,
21 CFR Part 11, and clinical trials methodologies.
- Excellent knowledge of Clinical Data
Management methodologies and current/emerging global Data Management
standards.
- Experience with Electronic Data
Capture (EDC) systems /methodology from a sponsor, CRO, and EDC vendor
perspective.
- Experience with working remotely and
with managing remote teams (including international project teams and
contractors).
- Strong written and verbal
communications skills, including technical writing and editing skills.
PRINCIPAL CONSULTANT August 2007 - Present
BioBridges, LLC Wellesley,
Massachusetts
Provided senior-level Clinical Data
Management consulting services to BioBridges clients including:
-
Direct
data management for in-house phase I-IV clinical trials.
-
Project
management of data management activities for studies outsourced to Clinical Research Organizations.
-
Guidance to corporate executives on data management
and regulatory submission strategy and execution.
-
Documentation of current and historical data
management and SAS programming activities.
-
Creation of Standard Operating Procedures for data
management and SAS programming activities.
-
Hiring and management of consultants and staff
performing data management and SAS programming activities.
-
Assistance
in writing and reviewing documents, including Statistical Analysis Plans and
Clinical Study Reports.
-
Assistance
in preparation of data for electronic submission to FDA.
LEAD CLINICAL DATA MANAGER July 2006 – August 2007
Created and managed a Data Management, SAS
Programming, and Monitoring department for Outcome (an EDC vendor and CRO
focused exclusively on post-marketing research/patient registries and phase IV
clinical trials).
Managed all of Outcome’s data management and
site monitoring needs. Hired and managed
staff of seven (four Clinical Data Managers, two Clinical Research Associates,
and one SAS Programmer consultant). Developed Standard Operating Procedures
(SOPs) and Working Practices (WPs). Managed clinical trial and patient registry
programs through review, cleaning, and auditing of clinical databases. Assisted
Business Development group in creation and defense of client proposals.
Performed SAS programming for internal and client projects.
Various Clients in United States and Canada
I worked as a
consultant in various aspects of clinical research data management for eight
years. During this time, I performed
data management, statistical analysis, and systems analyst duties in contracts
ranging from a few months to two years. Sample projects included:
- Provided data management expertise to a
new university-based Clinical Research Organization. Coordinated data
management of multicenter breast cancer study. Educated staff on clinical
trials and data management issues. Provided guidance on feature changes to new
Electronic Data Capture (EDC) system. Worked remotely from home with travel to
University and other sites as needed.
- Managed and maintained various databases
used by a Canadian university-based Osteoporosis research and treatment
program. Performed data quality control measures. Linked program databases to
other hospital, provincial, and national databases. Analyzed data using SPSS
and SAS. Served as the computer and statistical consultant for the
multidisciplinary staff of the program. Worked with other program members to
improve processes for data capture and analysis.
Asican
Rozar
Page
2 of 3
CLINICAL DATA
MANAGEMENT CONSULTANT (Continued) June 1998 – July 2006
Various Clients in United States and Canada
- Performed competitor assessment for a
small Canadian Clinical Research Organization who planned to add Clinical Data
Management to their existing services. Performed technology assessment for
Clinical Data Management services to company executives.
- Managed configuration and validation of an
Argus Safety installation for the new Pharmacovigilance department of a
biotechnology company that had just received FDA approval of their first
marketed product.
- Managed validation of upgrade of a
unix-based installation of Clintrial for Biometrics department of a small
biotechnology company. Revised all Standard Operating Procedures and Working
Procedures for Biometrics and Clinical Data Management departments. Created a
Master Validation Plan and procedures for SAS programming activities for
Biometrics department.
- Provided clinical data management
consulting and support services during the cross-country relocation of the
diagnostics division of a major international pharmaceutical company. Provided
training and monitoring for laboratory sites participating in device
(laboratory testing equipment) protocols.
- Provided Clinical Data Management support
services for US, Canadian, and European clinical trials for various clients.
PREVIOUS
EXPERIENCE
Clinical Database Manager (Staff) Columbia Research
Laboratories, Inc. September
1996 – May 1998
Clinical Data Manager (Contract) Genetics Institute March
1996 – August 1996
Clinical Data Manager (Contract) Serono Laboratories September
1995 – February 1996
Data
Management Consultant Various
Clients April
1995 – August 1995
Clinical Data Analyst (Contract to
Staff) Fujisawa USA, Inc. July
1993 – March 1995
Clinical Data Coordinator (Staff) Tulane-LSU AIDS Clinical
Trials Unit December 1991
– July 1993
Clinical Research Associate (Staff) Tulane-LSU AIDS Clinical
Trials Unit April 1991 –
November 1991
Research Assistant (Staff) New Orleans
Orthopedic Clinic June
1990 – March 1991
Research Assistant (Staff) Univ. of
Texas Medical Sciences Institute September
1988 – May 1990
EDUCATION
University of Texas School of Public Health Houston,
Texas
Master of Science
• Epidemiology August
1993
Tulane University New
Orleans, Louisiana
Bachelor of Arts
• Psychology/Political Science May
1988
COMPUTER
SKILLS
Operating Systems: UNIX
(RS6000, Sun); Windows (NT,2000,XP); Macintosh OS 10.4
Database Software: Oracle,
Microsoft Access, My SQL
Data Analysis Software: SAS,
Systat, Minitab, SPSS, EpiInfo, EpiData
Oracle Skills: Oracle 8i, PL/SQL, SQL*Plus,
Developer 6.0
SAS Skills: Base, Stat, Access, Graph
Clinical
Software: Clintrial,
eRT/eDM, InForm, Study Manager, Nextrials Prism, Medidata Rave, Inspire,
OpenClinica,
and proprietary systems
THERAPEUTIC
AREAS:
Female Health Organ
Transplantation Osteoporosis Assisted Reproduction
Hepatitis Mental
Retardation Cardiology Diabetes
Oncology Alzheimer’s
Disease AIDS/HIV Orthopedics
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