Manager Project

MAXINE OPPERMAN

*** *. *** **., *****, NY ***** phone: h: 347-***-****; c: 646-***-**** email: **************@*****.***

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PROFESSIONAL SUMMARY

Experienced Clinical Data Manager with knowledge of NDA process and how that translates into daily workday requirements from a data management standpoint seeks opportunity. My background in database programming and database design serve as a backdrop, and facilitate my hands-on understanding of EDC programs as well as systems from UAT and implementation to programming & data lock. I have an ongoing commitment to producing the highest quality data, databases, systems, reporting & analysis, reconciling SAE databases & data, through monitoring and overseeing edit checks and data queries, laboratory data analysis and conversions working with both local and central labs. My supervisory experience exceeds 10-years with emphasis on staff educational development.

Areas of Expertise

HIPPA, GCP, ICH, FDA compliance Data cleaning, close/lock procedures

Implement software, upgrades, UAT Project Management, scheduling in CDM

Train and mentor new staff Supervise staff & oversee CROs

Database design, set-up and maintenance

Create/program reports, develop presentations

Write database specifications, data dictionaries, documentation, SOPs & work guidelines and annotate CRFs

Data Manager II– 2011- Present

Symbio Research, Port Jefferson, NY

Design and write manual queries for mostly phase 3 studies.

Review edit checks and programmatic results for edit checks.

Review new study protocols, SOPs, Case Report Forms (CRFs), Data Management Plans and Data Completion Guidelines

Clinical Database Manager - 2007 - 2011

The Population Council - Center for Bio-Medical Research (CBR), New York, NY 10021

Data management oversight of all clinical trial studies both international and domestic in Reproductive Health, including legacy studies. This includes project management, scheduling and data cleaning from study start-up through to data lock & archive for phase I through phase 3 studies.

Team leader in the production of the data management component of NDA.

Write data dictionaries, annotate CRFs, write data management plans, develop laboratory conversions for standardized reporting, define edit checks, oversee query definition identification and query reporting & resolution to all sites.

Audit and oversee CRO’s ensuring appropriate, accurate and consistent data and database results.

Developed interim reports of efficacy and safety creating SAS data sets as needed for SERC, ICCR conferences and special presentations.

Data Management clinical trial software administrator. Implementation of software upgrade/migration; data validation and documentation.

Acceptance Test Kit (ATK) software validation.

Design and implement staff training modules for clinical software, maintain user permissions, re-set passwords.

Project Manager, 2005 - 2007

Royal Health Care, New York, NY

Development of enterprise-wide data warehouse (DW) for Medicare product for analytical reporting and ad-hoc query purposes.

Maintained Medicare compliance oversight; Identified areas of weakness, built & implemented corrective processes;streamlined automated solutions.

Developed specifications for programmers;

Wrote procedures & documentation for RAPS insurance claims data, drug data files, medical & prescription drug ID card production;

Developed automated Medicaid status update system & HMO medical drug & benefit cards.

Director of Data Management - 1998 to 2005

ESRD Network of NY, New York, NY

Managed Data department staff; maintained computer hardware, LAN and software installations & upgrades.

Provided software training in-house and across NYS supporting over 250 facilities in conjunction with the implementation of new remote, facility-specific data-entry, data reporting and Medicare compliant proprietary renal software.

Ensured CMS regulatory data compliance of all NYS Medicare-certified dialysis and transplant facilities.

Provided ad-hoc reporting in SQL Server to NYS-DOH, USRDS, and other entities; developed internal metrics for review and evaluation; Converted/upgraded all system-wide data to SQL Server.

Maintained clinical databases of renal patients & all Medicare certified facilities across NYS.

Developed QIPs (quality improvement projects) for staff improvement; developed data and database templates for state-wide patient QIPs. Developed internal quality assurance plans.

Data Systems Manager - 1997 to 1998

Healthy Start, New York, NY

Developed databases, programmed applications and modified specifications for federal demonstration project per 3 low income NYC neighborhoods to reduce the incidence of infant mortality; Developed vial statistics databases; Provided ongoing consulting services.

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Education

BA Economics - SUNY Oneonta

MA Candidate Economics - NYU Graduate School of Arts & Sciences

Ph.D. coursework - NYU

Continuing Education

Oracle Corp. - Advanced Database Design

HTML Programming - Fund for the City of NY

Advanced MS Access Programming

DataFax - Edit Check Programming, System Administration

Publications

The effect of Glycosylated Hemoglobin and Lipids on Survival in Diabetics Receiving Dialysis, American Journal of Kidney Disease.

References Available Upon Request

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