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- 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 rglements 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 C Graduated