G ermine Meterial

Professional Summary

• Drug Safety

AREA OF EXPERTISE

• Clinical/PreClinical Trials

• Project Manager

• Business Analyst/Subject Matter Expert

• Validation Lead

• Drug Safety Associate

ROLES

• Developer

• Trainer

• Drug Metabolism Chemist

• Process Manager

• Electronica Data Capture- Expert, Rave, Oracle Clinical, DataLab’s EDC

• Drug Safety Application- AERs, ARISg, Argus, Alert, Clintrace

APPLICATIONS

• Miscellaneous: ClearCase, Seapine, Tracker, Dimensions, MedDRA, WHODrug

• CTMS: Siebel, eStudy Conduct/Site Monitor

•

DATABASE Oracle, SQL, Access

•

TECHNICAL LANGUAGES VB, VBscript, Javascript

• ICH, E2B

• CFR21 Part11

•

REGULATIONS CDISC

• Company SOP

• GMP, GCP, GLP

•

TOOLS TOAD

• Validation- Test Summary Plan, Test Case, User Acceptance Testing Scripts, OQ,

IQ, PQ

• BA- User Requirements, Data Mapping documents, SOP

DELIVERABLES

• Development- Data Migration documentation

• Trainer- User Training Material, Training enviornment

Order holds no relevance as to knowledge for objects listed in this table

Professional Experience

Sage Quest Global Solutions

Boston Scientific <Jul 2004– Present>

-Informational Systems Project Manager

• Create weekly status reports to ensure that expectations are met

• Conduct weekly status meetings to ensure timely deliverables

• Coordinate resource assignments

• Ensure all resources are properly trained for project needs

• Create of project timelines and planning delivery schedule

• Maintain issues, risks, decisions and change management database; pro-actively working to

resolve the issues and monitoring progress on risk mitigation

• Prepare project timesheets, updates, proposals and monthly and quarterly reports

• Manage off-shore teams

• Consult with customers to ensure contractual conformity

• Coordinate with business for business line deliverables such as internal and external

communications, training, procedures (SOP) and User Acceptance Testing

• Developing PowerPoint presentations for periodic business/sponsor updates

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• Guiding project team members, contractors, and vendors as necessary

• Modify/Author training material

• Evaluate effectiveness of training and adjust plans/training strategy as needed

• Serve as a principal contact for user problems/concerns and address them through

retraining(when/where possible)

• Define longer term system enhancements to address problems

• Represent end users to production support teams

• Prioritize trouble tickets

• Create custom reports

• Software includes: Athena, Visual Source Safe, Microsoft Office tools

-Developer

• Demonstrated knowledge of system development life cycle (SDLC) and produce and/or

modified documentation requirements to support customer needs

• Created configuration specifications based on user requirements

• Configured application based on configuration specifications

• Developed derivations, Oracle triggers, and consistency checks based on client specifications

• Performed peer code review/unit testing

• Designed system pages as per requirements

• Implemented integration of CTMS/eDC system

• Customized reports

Software includes: EXPERT, RAVE, eSafety Net, Oracle Clinical, Siebel CTMS Microsoft

-Validation Lead

• Executed IQ scripts

• Created OQ and PQ scripts

• Authored Test Summary Reports, Test Scripts, Test Plan

• Validated Compensation of CTMS/eDC system

• Worked directly with the Global IT plan/build project and Business teams to define and develop

testing strategy and testing requirement/timing based on business requirements and change

controls

• Provided input to the User, Functional and Technical specification documentation

• Managed test case(s)/plan development

• Managed, tracked and trended test case execution

• Managed and tracked defects and resolutions of defects.

• Provided metrics and analysis for system readiness and release.

• Participated as a CAPA team member/owner-responsible for creating, reviewing and/or approving

documentation within CAPA activities.

• Software includes: EXPERT, RAVE, Siebel CTMS Microsoft Office tools

CSL

-Process Manager

• Developed process strategies to meet client’s unique needs

• Implemented strategic vision of a client program through the creation of optimized, unified

processes

• Built new workflows

• Adviced client on how to utilize systems to create an optimized process

• Authored and/or reviewed SOPs, Work Instructions, Guidelines, Training Material and Best

Practices

• Coached and managed business analysts to ensure business tasks and workflow are

analyzed globally across departments/functions in order to improve, measure, and maintain

processes

• Navigated and negotiated conflicting requirements and priorities across stakeholder groups

• Communicated changes to audience

• Provided management with visibility across initiatives so that they may understand progress,

performance against metrics, and dependencies among initiatives

• Requested feedback from business units to continuously improve quality

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• Audited data integrity issues

• Gathered information for ad hoc reporting requests

• Analyzed Data for positive trends and best practices

• Created/Delivered training material

• Software includes: SharePoint, Microsoft Office tools

Pfizer

-Drug Safety Application Business Analyst

• Delivered the data mapping document, user requirements document, system requirements

for migration of 250,000+ cases from legacy applications such as MEDS, MEDICS,

NOVALERT, ARGUS 2.9.1, ARISg to ARGUS 4.2

• Provided the data mapping document and user requirements document for migration of all legacy

data e2B format for an xml submission of the backlog

• Offered business expertise with all aspects of deployment services

• Reviewed with business all data changes that need to be made in order to migrate legacy data to

e2B format

• Supported Data clean up activities

• Managed report requests

• Software includes: Argus, ARISg, NOVALERT, MEDS, Microsoft Office tools

Cubist

-Drug Safety Associate

• Receive, track, report and ongoing management of serious and non-serious adverse events

• Create and review aggregate annual/periodic safety reports

• Data Analysis and reconciliation

• MedDRA and WHO-Drug coding

• Submit cases electronically

• Software includes: Oracle AERS, Microsoft Office tools

eResearchTechnology, Inc

-Clinical Project Manager for Cardiac Safety <Jun 2000 – Jul 2004>

• Collaborated with the Sales/Business Department to identify non-standard client expectations, as

well as identify upcoming projects for proper team preparation prior to client project kick-off

meetings

• Reviewed business contracts, as well as protocol to ensure detail consistency

• Identified/Recruited proper resources

• Met with project team prior to project launch to review timelines, expectations and identify

potential concerns

• Managed internal and client team members in order to ensure focus on timelines and deliverables

• Prepared necessary documentation to ensure milestone and expectation awareness

• Provided clients with weekly status reports detailing metrics, outstanding issues and suggested

solutions

• Accurately forecasted project expectations to identify revenue

• Consulted with project teams to ensure commitment to deliverables and timelines

• Assisted in setup Implementation Procedures to improve efficiency and reduce errors

• Met with client at project closure to identify areas of improvement

• Adhered closely to company SOPs

• Served as primary client contact at the project operational level ensuring quality services and

attention to changing needs.

• Established contingency plans for key resources

• Trained resources and clients

• Developed project training material

• Customized/presented training material at investigator meetings

• Software includes: EXPERT, Microsoft Office tools

-Technical Project Manager < Jun 2000 – Jul 2004>

• Collaborated with the Sales/Business Department to identify upcoming project expectations.

• Marketed company’s application capabilities to potential clients

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• Reviewed Global Client Processes for Drug Safety Departments

• Identified client process for the purpose of automating and expediting the efficient processing of

safety data.

• Created User Requirements

• Created Configuration Specifications based on User Requirements

• Configured Application based on Configuration Specifications

• Created OQ and company specific PQ

• Created client training manuals for Safety implementation

• Performed client training on Safety software

• Created company specific SOPs

• Created Installation Qualification Kit

• Executed Installation Qualification

• Completed several software implementations for Drug Safety Departments

• Created Derivations, Oracle Triggers and Consistency Checks based on client specifications

• Collaborated with management to create Implementation Certainty to ensure Project Success

• Resolved software issues by effective troubleshooting

• Preformed strategic as well as ad hoc data analysis to ensure data integrity

• Reviewed Marketing material for vendor’s Safety product

• Software includes: SQL, eSafety Net, Microsoft Office tools

Knoll Pharma (BASF)

- Drug Safety/Pharmacovigilence/Data Coordinator(Consultant) < Feb 2000 – Jun 2000>

• Wrote medical naratives for prescription and investigational drugs

• Assisted in writing narratives for Periodic Report

• Performed ad-hoc querries through Clintrace using SQL

• Maintained and updated PSUR (Product Safety Update Report) tracking database

• Utilized knowledge of MDR, ICD-9 and coding dictionaries to make reportability decisions

• Prepared regulatory submission documents including 3500A forms, and CIOMs

• Trained coworkers on database functionality

• Monitored adverse events by obtaining and reviewing additional information

• Software includes: SQL, CLINTRACE, Microsoft Office tools

Warner Lambert-Parke Davis

- Product Safety,Surveillance/Data Coordinator(Consultant) < May 1999 – Feb 2000>

• Executed test scripts for validation

• Performed Ad-hoc queries using ARISg and ALERT

• Monitored adverse events by obtaining, reviewing additional patient information

• Trained co-workers on database functionality

• Software includes: ARISg, ALERT, Microsoft Office tools

Ortho-McNeil Pharmaceuticals(Johnson & Johnson)

- Scientist Associate Quality Control/Quality Assurance(Consultant) < Oct 1997– May 1999>

• Analyzed raw materials used in drug formation and drug analysis

• Analyzed samples according to the company Specifications, USP, and USP-NF

• Operated FTIR, UV and Colorimeter

• Mastered various types of experiments such as: Loss on Dryness, Substance Oxidation

• Invited/joined safety committee to ensure departmental safety and compliance with OSHA

• Software includes: LIMS, Microsoft Office tools

Novartis Pharmaceuticals

-Associate Scientist-Drug Metabolism Pharmokinetics(Consultant) < Mar 1997– Oct 1997>

• Performed method development and validation on the analysis of drugs in biological fluid

• Produced excellent standard curves for HPLC as well as mass spectrometry

• Calibrated and utilized automated equipment

• Reviewed peer results for percision, accuracy and compliance to GLP and cSOP

• Software includes: LIMS, Microsoft Office tools

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Huntingdon Life Sciences

-Associate Scientist-Drug Metabolism Pharmokinetics(Consultant) <Aug 1996– Mar 1997>

• Prepared various concentrations of drugs, and analyzed these concentrations on HPLC to

determine accuracy and precision

• Prepared validation and analytical reports and SOPS

Education/Training

• Bachelors of Science, Biology, Rutgers University

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