Sammary

GOAL To obtain a position which will utilize my data management and batch record review

skills while allowing me to acquire new skills.

PROFESSIONAL

Contract Document Control Specialist

confidential

EXPERIENCE

Provide project support using a Quality Documentation Management System

within the Quality Documentation department. Specific duties include data entry and

data verification, extraction of data from database to Excel spreadsheet, reconciliation

of processed documents, scanning, filing, and other project needs. Daily use of Excel

and FileMaker Pro 10.

Contract Data Coordinator

confidential

Data entry of large volumes of data from historical Manufacturing Batch Records into

Excel spreadsheets. This historical data will be used to perform a retrospective

analysis to evaluate how the manufacturing process has been controlled in past years.

This data will be used to help modify or develop a control strategy on the current

manufacturing process.

Contract Manufacturing Technical Services

confidential

Enter and authorize data from Manufacturing Batch Records MBRs into LIMS

and Excel for data trending purposes, maintain an Excel tracking spreadsheet,

gown and degown per Standard Operating Procedure SOP in order to gain access

to ISO Class 7 and 8 clean rooms to perform the data entry and authorization

activities, review data entry SOPs for content and clarity.

Contract Clinical Data Manager

confidential

Audit calibration data by comparing source documents against printed reports,

verify calculations on the source documents for correctness, and data entry of

calibration data into an Excel template. Data entry of .pdf eCRFs into Medidata

Rave v. 5.5.1. Run and send to medical monitors a daily Medidata Entry Issues

report to ensure timely resolution of sites' data entry issues.

Contract Business Data Entry Specialist

confidential

A member of the Commercial Analysis team with a focus on improving customer

information by gathering new information and transferring existing data into a

customer information management system SalesLogix 7.5.1 . Specific

responsibilities include researching health care practitioners and medical

institutions on specific websites to gather contact and profile information,

entering this data into a Microsoft Excel spreadsheet or into the SalesLogix data-

base, providing status reports and updates on assigned tasks, and communicating

to management any issues in locating or capturing accurate customer information.

Contract Product Support Associate

confidential

Process orders for patients' Type 1 diabetes management products using MS

Dynamics AX and Salesforce.com, a Customer Relationship Management CRM

System.

Contract Clinical Data Manager

confidential

Perform data review and discrepancy management for a large inhaled insulin study.

Specific duties include review of data according to Data Validation Plan DVP ,

query generation and integration, and communication of data management issues to

the primary Clinical Data Manager.

Contract Data Analyst

confidential

Perform data review and discrepancy management using InForm 4.0 Electronic

Data Capture for a large multiple sclerosis clinical trial. Specific duties include

review of data according to DVP, query generation and resolution, freezing and

unfreezing of specific eCRF screens, creating listings for data review, communicating

data management issues to the data management team, and testing of the InForm 4.5

database with mock data prior to migration to InForm 4.5.

Contract Clinical Data Manager

confidential

Responsible for assisting the Clinical Research Manager in developing the

data management process for a start-up medical device company. Primary

responsibilities include assisting with the creation of Data Management SOPs,

receipt and tracking of CRFs, CRF review, query creation, integration, and tracking

into a query database, and data entry of clinical trials data.

Contract Clinical Data Specialist, confidential

Scan CRFs/DCFs to a pdf file, first pass data entry using Oracle Clinical 4i,

quality control QC of audit listings to ensure all intended data points are

captured on the audit listing, and auditing of the database against the CRF

prior to database lock for this Phase II renal cell carcinoma clinical trial.

Contract Study File Analyst

confidential

Perform site level review of documents such as Form 1572,

Investigator Financial Disclosure Forms, IRB Correspondence, Clinical

Laboratory Reports, Investigator Brochures, INDs and other site level

documents in preparation for an FDA/EMEA audit.

Contract Clinical Data Manager

confidential

A short term contract writing and integrating queries and using SAS

generated listings to perform discrepancy management.

Contract Clinical Data Manager

confidential

A short term contract performing manual and electronic edit check review and

query generation and integration for a medium sized Phase III clinical trial.

Contract Clinical Data Coordinator

confidential

Perform data review and query generation/integration for a large Oracle Clinical

based breast cancer clinical trial, creation and entry of mock data to ensure

accuracy of the validation specifications, perform second pass data entry, maintain

an Excel spreadsheet of missing CRF pages and query site for those missing pages.

Contract Clinical Data Specialist

confidential

Data review and querying of a large clinical trial 1600 patients evaluating the

use of a drug-eluting coronary stent using Medidata Electronic Data Capture EDC .

Perform extensive review of data listings to identify and correct data discrepancies.

Contract Clinical Data Manager

confidential

Perform manual and electronic review of patient data, query generation/integration/

quality control QC of integration, QC of the database using SAS listings, make Self-

Evident Corrections SECs to CRFs according to Data Review Guidelines DRGs

and SOPs, and perform mapping of local laboratory data to ensure consistency with

database structure for this small prostate cancer study.

Contract Clinical Data Manager

confidential

A short term contract for a carotid stent clinical trial where the main objectives

were to enroll patients into the study, make Self-Evident Corrections SECs to

CRFs, and to perform query integration.

Contract Clinical Data Manager

confidential

Perform quality control auditing of the clinical database by comparing SAS listings

of the database against the CRFs and correcting all self-evident discrepancies.

Contract Data Analyst, confidential

Perform manual and electronic edit check review, reconciliation of data

discrepancies through generation of data correction forms DCFs , updating

of the query system, clinical database, and CRF based on DCF resolutions, and

provide ongoing feedback on data management workflows to increase efficiency.

Contract Clinical Data Coordinator

confidential

Entry of test patient data, quality control QC of validations, data entry of CRFs

into an Oracle Clinical database, quality control auditing of database using SAS

generated listings and organization of data management files.

Clinical Data Associate

confidential

Ensure the integrity of Clintrial based clinical trials databases according to SOPs

and in accordance with GCP. Perform manual and electronic edit check review

of data, query generation/integration, track the data management status of CRFs,

and participate in weekly team meetings to discuss data review guidelines and data

flow procedures. Therapeutic areas worked on included diabetes and asthma/allergic

rhinitis.

Data Support Associate

confidential

Perform receipt and tracking of CRFs from site, pre-entry preparation of CRFs,

train newer team members for the pre-entry preparation task, first and second

pass entry of clinical trials data, perform database audits.

EXPERIENCE

4.0, Medidata Rave 5.5.1, Documentum EDMS 5.0 , Microsoft Word, Excel, and

Outlook, Lotus Notes, Novell GroupWise 6.5, Windows 2000, XP Professional

and Vista, Microsoft Dynamics AX-1, Salesforce.com a Customer Relationship

Management CRM system , Sage SalesLogix 7.5.1, GeODE General Office

Document Entry , LIMS Laboratory Information Management System , TrackWise.

SharePoint, FileMaker Pro 10.