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Project Manager Data

Dover, Delaware, United States
January 28, 2018

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Rosemary Price

*** ******* *****

Smyrna, DE ****7

Phone Number: 302-***-****

IT Quality Assurance Specialist position where I can utilize my expertise in systems software by testing, analyzing and detecting problems in database management. Work Experience

Co-owner, Vendor Manager, Beertender

Blue Earl Brewing Company

Smyrna, DE

July 2014-Present

Quality Assurance Analyst (QA Analyst)


Milford, DE

July 2014-September 2017

• Design test plans, scenarios, scripts, or procedures

• Document software defects, using a bug tracking system, and report defects to software developers

• Identify, analyze, and document problems with program function, output, online screen, or content

• Experience with: Bugzilla, Desktop computers, jQuery, Laptop computers, Microsoft Internet Explorer, Microsoft Office software, Microsoft Visio, Microsoft Windows IS/IT Project Manager, Contractor

Klein Hersh

Willow Grove, DE

December 2013-February 2014

• Performed a project manager role as a Clinical Business Analyst and supported the R & D IT Director by identifying clinical trial reporting and analytical needs.

• Assisted in running business requirement workshops to define the organization’s clinical reporting and metrics needs.

• Develop implementation plans that include analyses such as cost-benefit or return on investment


• Defined requirements for Clinical Operations Analytics tools

• Evaluated and selected new tools to support the generation of reports, metrics and data mining including Clinical Trial Operations and Safety/Efficacy Data.

• Planned, developed executed an eClinical Analytics Roadmap. IT Principal Consultant

Oracle HSGBU

Conshohocken, DE

January 2010-January 2014

• Performed a Project Management role as a Principal Consultant for a leading software application tool with particular focus on the delivery of solutions within the life sciences industry.

• Develop and manage work breakdown structure (WBS) of information technology projects.

• Develop or update project plans for information technology projects including information such as project objectives, technologies, systems, information specifications, schedules, funding, and staffing.

• Manage project execution to ensure adherence to budget, schedule, and scope.

• Prepare project status reports by collecting, analyzing, and summarizing information and trends.


Project Manager, Validations Associate

Data Labs, ClinPhone, Perceptives Informatics

Conshohocken, DE

August 2006-March 2010

• Provided implementation of technology and process solutions for clinical research, pharmaceutical or biotech fields in a Project management role.

• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.

• Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.

• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.

• Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.

• Design validation study features, such as sampling, testing, or analytical methodologies.

• Created and executed project work plans and revised as appropriate to meet changing needs and requirements.

• Prepared for presentation and training at Investigator Meetings, on-site training and Boot Camp Training and Demo’s.

• Minimized exposure and risks on project by adhering to all 21 CFR Part 11 rules, HIPAA Guidelines and GCP Principles. Analyzed project profitability, revenue, margins, bill rates and utilization.

Clinical Research Associate (CRA)

MedFocus-Astra Zeneca

Wilmington, DE

January 2006-July 2007

• Design and validate clinical databases including designing or testing logic checks

• Process clinical data, including receipt, entry, verification, or filing of information

• Interacting with Computers

• Documenting/Recording Information

• Experience with: Clinical trial management software Clinical Research Associate (CRA)

Christiana Care Health Services

Newark, DE

April 1990-December 2005

• Process clinical data, including receipt, entry, verification, or filing of information

• Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems

• Develop project-specific data management plans that address areas such as data coding, reporting, or transfer, database locks, and work flow processes

• Experience with: Clinical trial management software, Drug coding software, Electronic data capture EDC software

• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.

• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.

• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.

• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.

• Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.

• Code, evaluate, or interpret collected study data.

• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.

• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.


High School Diploma

Thomas McKean High School

Wilmington, DE

September 1974-June 1976

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