Dolores Stadtmauer has over 20 years of experience in clinical drug development and pharmaceutical safety. Her experience includes 10 years at Bristol-Myers Squibb as a Safety Regulatory Associate and Clinical Data Examiner, where she processed adverse drug events, coded medical data, and ensured clinical studies adhered to good practices. She has strong analytical skills and a proven ability to meet timelines in challenging environments.

1. DOLORES M. Stadtmauer
Ocala, Florida
SUMMARY OF QUALIFICATIONS
More than twenty years of experience various Including ten years of solid
experience in the clinical drug development process Pharmaceutical and drug
safety. Major Strengths: a solid work ethic, a mind for analytical detail, and an
Ability to meet timelines in a challenging environment.
BUSINESS BACKGROUND
BRISTOL-MYERS SQUIBB COMPANY - HOPEWELL, NJ
Safety Regulatory Associate - Drug Safety & Pharmacovigilance GLOBAL &
Labeling 04/99 - 10/05
Possess detailed knowledge of all Adverse Event processing, e / g product
label / reaction assessment, medical coding and medical narrative writing
deferrals to the FDA. Processes broad volumes of Adverse Event (AE)
deferrals in GPV (Drives Performance, People Develops, Leads Strategically
energizes and Others). Queries Medical Directors and BMS in a Timely
Manner affiliates for clarification of deferrals to the FDA. (Builds Alignment,
Clearly Communicates). --other Supports teams in Adverse Event processing
(Collaborates).
Process Adverse Event boxes as Efficiently as possible, commensurate with
speed, quality, accuracy, and medical safety.
Assess whether an adverse event is listed there product's label; Code refer to
terms MEDRA: conduite and follow-up with the querying refer (s) to capture
additional relevant data.
Employed physicians as medical surveillance resource for spontaneous event
processing.
Trained our new (Over The Counter) Product Team members for clinical
studies and spontaneous reports.
Attended training classes for:
1. Micro Medex Training Seminar for Global Pharmacovigilance & Drug Safety
& Labeling.
2. Writing, Editing, and Proofreading.
3. Written Communication.
4. Communicating with Confidence
5. Medical Terminology (Continuing Education).
6. Global Pharmacovigilance & Drug Safety & Labeling - Scientific Writing.
7. Electronic Records, Electronic Signatures FDA Regulation (21 CFR Part 11).

2. Awards: Excellence Award Earned the Presidents
Dolores M. Stadtmauer - Page 2
BRISTOL-MYERS SQUIBB COMPANY - Plainsboro, NJ
Clinical Data Examiner - Data Management / Bio-Statistics 10/91 - 04/99
Data Management Project Leader overseeing the manufacture of clinical
studies from Beginning to end.
Perform processing of Serious Adverse Events, Codes for Medical Laboratory
Lab Normals, Co-start -CV, ONC,AIICNS, Lab tests, ICDA - Body systems &
Terms Primary dictionaries.
Perform quality data entry / validation, modification of clinical research data for
Post-Marketing III B and IV with the VAX / ORACLE IBBN Clintrial 4.1 Studies
and Clinical Systems on IBM VM / IMS Following in the therapeutic areas:
1. CNS - Central Nervous System
2. AI - Anti-Infective
3. CV - Cardiovascular
4. ONC - Oncology
Develop database design to multiple screen panel Produce / forms for the
VAX IBBN Clintrial 4.1 Clinical Studies Systems.
Prepare clinical data for input to the computer system.
Develop SAS programs to perform data integrity checks and generate
standard summary reports.
Work Closely with Statisticians, clinical monitors, and data management staff is
generation data management and processing queries.
Prepare for data entry queries to review the medical investigators at Their
clinical study site.
Updating status deferrals for outstanding queries.
Ensuring all activities adhere to Good Clinical Practices and règlements to
company standard operation procedures. Maintain master files and related
records of project documentation for Ongoing Projects.
Knowledge of Biomedical and Clinical Laboratory Tests Terminology / Lab
Normals.
Train clinical data processors in new projects.
Interview potential candidates.
Dolores M. Stadtmauer - Page 3
Training and Development Center
1. Good Clinical Practices.

3. 2. Clinical Data Management in Pharmaceutical Research and Development.
1. Leadership and Team Building Program.
1. Fundamental Presentation Skills.
1. Franklin Planner / Time Management Course.
2. Employee's Role in Career Development.
3. Medical Terminology Course in 1991.
4. Reading for Increased Productivity.
5. Listening for Increased Effectiveness.
6. Writing for Impact.
7. Vocabulary Power.
8. PDP - Phase I and II for Professional Development Support Staff
9. Enhancing Professional Image.
10. Break-it Thinking, Creative and Innovative Thinking / Critical Thinking
Relationship Skills
Dolores M. Stadtmauer - Page 4
Leadership Core BMS Behaviors / To our accountability for our results and
Behaviors. To build high-performance business That with The Highest Culture
of integrity and reach our goals. Our pledge to our customers, to our
colleagues, to our suppliers, to our Shareholders and to the Communities
Where We Live and Work, the countries Where We do business and the world
we serve.
Strategically Leads
Builds Alignment
Communicates Directly
Drives Performance
Collaborates
Energize Others
Develops People
Computer Training:
Microsoft Office
SAS Programming
R2W for Windows UNIX / N / T 5.20
Introduction to Unix and Shell Programming Language
PREVIOUS EMPLOYMENT
Details available on request
SUPREME COURT OF NEW JERSEY TO 8/88 10/91
Secretary for Legal Fee Arbitration Attorneys (Office of Attorney Ethics of the
Supreme Court of New Jersey)

4. Aries 2/84 to 7/88 Computing Corporation
Data Processing Consultant
President
EDUCATION
Irvington High School - Irvington, NJ - Graduated
Bergen Community College – Graduated