Manager Project

[pic]MAXINE OPPERMAN

*** *. *** **., *****, NY **458 home: 347-***-**** cell:

646-***-****

email: **************@*****.***

PROFESSIONAL SUMMARY

Experienced Senior Data Manager with extensive knowledge in bio-medical

research/clinical trials, healthcare and data management seeks challenging

opportunity.

Committed to highest quality data, database systems, analysis;

Hands-on IT knowledge, strong knowledge of database software applications,

seeking to provide analysis and implementation solutions; background in

database programming and database design serve as a backdrop for problem

solving; Legacy system conversions;

Design and implement technical, software solutions, training, UAT, system

administration;

Management experience; Supervise staff, team leader, oversee all aspects of

data management, data mapping, data mining, write technical documentation,

analysis; Program ad hoc reports, tables, charts & presentations.

Project management of larger system wide development, modifications and

updates through complete scoping, corroboration, business plans and

specifications.

AREAS OF EXPERTISE:

HIPAA, NYSDOH, GCP, ICH, FDA regulatory compliance

Project Management (task scheduling, time management)

Manage/audit vendors, consultants, CROs

Software/compliance training;

Create/program reports, develop presentations;

Data cleaning/QA, validation, lock/archive procedures;

Supervise medical coding, data-entry, SAS programmers;

Computer expertise using MS Office, SQL Server, T-SQL, EMR/EHR, DataFax

EDC;

PROFESSIONAL EXPERIENCE

CLINICAL INFORMATION ANALYST - 2013

Callen-Lorde Community Health Center, NY, NY

Database analysis, EMR/EHR review (NextGen), SQL Server, T-SQL, MS Access;

Business plans documented for HIT system-wide modifications and updates

from user corroboration.

Ad hoc reporting from EMR/EHR back-end;

Built federal and State government required periodic reports and grant

reporting: demographics, payer, FTE reports, UDS.

Analysis and development of internal metrics per utilization, PI and

business indicators.

Design front-end applications for internal departmental review and

analysis.

DATA MANAGER II 2011 - 2012

Symbio Research, Port Jefferson, NY

Design and write manual queries for mostly phase 3 studies.

Review edit checks, data validations and programmatic results.

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, HIV, including legacy & paper studies.

This includes project management, scheduling, data cleaning/quality from

study start-up through to data lock & archive for phase I through phase 3

studies - from project scoping, daily workplans, written plans and

revisions for each iteration.

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

including day-to-day developments, reprioritizing.

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 ensure/validate appropriate, accurate and

consistent data, databases & regulatory compliance.

Development of 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. Implement software

upgrade/migration; data validation and documentation.

Acceptance Test Kit (ATK) software validation, UAT as per regulatory

requirements.

Design and implement staff training for clinical software, maintain user

permissions, re-set passwords.

Slice and dice databases using SAS and SQL; Database set-up in EDC

(DataFax).

PROJECT MANAGER 2005 - 2007

Royal Health Care, New York, NY

Developed enterprise-wide data warehouse (DW) for Medicare product for

analytical reporting and ad-hoc inquiry.

Maintained Medicare compliance oversight; Identified areas of weakness,

built corrective processes based upon complaints /compliance failure;

streamlined automated solutions.

Translated technical CMS documentation for in-house staff.

Developed/documented/logged programmers specifications and results;

Wrote procedures & documentation for RAPS insurance claims data, drug data

files, medical & prescription drug ID card production;

DIRECTOR OF DATA MANAGEMENT 1998 - 2005

ESRD Network of NY, New York, NY

Managed Data department and staff; Managed computer hardware, LAN and

software, installations, upgrades & troubleshooting problems;

Provided software training in-house and across NYS supporting over 250

facilities in conjunction with implementation of new remote, facility-

specific data-entry, data reporting Medicare compliant proprietary renal

software.

Ensured CMS data compliance by all NYS Medicare-certified dialysis and

kidney transplant facilities.

Provided ad-hoc and required routine reporting in T-SQL to NYS-DOH,

USRDS, and other entities; developed internal metrics for review and

evaluation; Converted/upgraded all system-wide data from antiquated legacy

system to SQL Server.

Maintained clinical databases of renal patients (demographics, mortality,

co-morbids), all Medicare certified renal facilities.

Developed QIPs (quality improvement projects) for staff improvement;

developed data and database templates for state-wide patient QIPs.

Developed internal quality assurance plans.

Participated/contributed in quarterly Medical Review Board (MRB)

meetings; Participated and presented in annual CMS meetings.

Data Systems Manager 1997 - 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

database; Provided ongoing consulting services.

Education

BA Economics - SUNY Oneonta

MA Candidate Economics - NYU Graduate School of Arts & Sciences

Continuing Education

Oracle Corp. - Advanced Database Design

HTML Programming - Fund for the City of NY

Advanced MS Access Programming

DataFax (CDMS) - Edit Check Programming, System Administration

Series 7 Training

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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