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Project Manager Management

McHenry, Illinois, United States
January 01, 2018

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

McHenry, IL *****

Phone: 715-***-****

Gloria C. Warren

Homeland Security Environmental Protection Specialist

**** – Present PM Consultant BUSINESS DEVELOPMENT: Auction House, Antique Mall, Classic Car Brokerage and other small businesses. All infra-structure, Accounting, Contracts, Management etc… Full scope Project Management from vision to Deliverables integrating the PMI PMBOK philosophies including Six Sigma, LEAN, Agile methodologies & Scrum Master techniques.

2001 - 2010 Biodiesel II, LLC BUSINESS DEVELOPMENT: Scientific Liaison (EPA environmental impact planning and compliance) for Esterhol fuel and establish business organizational development: Initiated investor relations, corporate infrastructure, & manufacturing facility, and strategic Business Plan Development (cost, risk, etc…). A subsidiary of Synovation Laboratories, LLC (wind, water, fuel & solar energy research lab/think tank); Subject Matter Expert: Jatropha International project development and implementation in China.

2/2001 – 7/2009 Construction Management Advantage OWNER; CONSTRUCTION PROJECT MANAGEMENT SERVICE Business Development, Project Development and Project Building including Negotiations, Budgeting, Contract Reviews, Directing Contractors/Subcontractors, Quality Control, Compliance etc… East 97th Street Green Project - 24 Energy Sustainable Town homes for Mayor Daley and Developers, (sold project in July 2006). Co-Project Manager: Whispering Meadows Green Home Development, Chesterton Indiana; 27-acre Green home energy self sustainable community. Entire developed project sold July 2006: 6659 S. Perry Ave, Chicago Condominium Project 12 Condo/Duplex units Completed in 2002. Build completed and Profit exceeded 600,000. Further projects include an Indiana Museum, Water Bottling Facility in Arizona & Northshore Homes.

12/2004 – 12/2005 COL Scientific @Abbott Pharmaceuticals MEDICAL SPECIALIST Safety quality assurance and product pharmacovigillance. Develop, ensure, train & test all Abbott Safety professionals including physicians, management and call center for Adverse Event case processing, review, reporting & compliance within regulation timeframes. Team Lead on development & implementation of “Medra Coder/Browser” software within FDA, CFR 21, ICH & GCP guidelines. Developed all training/documentation and implementation of training on all clinical systems. Daily Medra final code review/reconciliation and Adverse Events submission to FDA.

10/2004-11/2004 Consultant, Eli Lilly Lead Project Consultant of corporate all clinical studies data transfer to new software system. Review and validate after completion include all regulatory requirements and data validation according to FDA, CFR 21, ICH & GCP guidelines. (6-week assignment).

4/2003 – 7/2003 Tac Worldwide @Abbott Pharmaceuticals MEDICAL REVIEWER

Consultant: Review +20,000 pt global Verapamil calcium/non-calcium antagonist comparison

study. Reconciliation of clinical & safety databases; QA of SAE data listings and documentation in comparison with the package insert; In depth investigation/resolutions and QA of all safety reportable events. Reformatted all the necessary files for review per FDA guidelines; troubleshot program issues; identified shortcuts within utilized software. Utilized AEGIS database as well as off-site university research databases.

5/2002 – 12/2002 Tac Worldwide @TAP Pharmaceutical Products REGULATORY SPECIALIST

Consultant: Preparing UPRIMA Electronic NDA Submission (120 studies) first (historic) electronic FDA submissions, Compliance of Federal Policies, Regulations (CFR 21, ICH & GCP Guidelines).. Review of electronic reports and documenting errors within reports (Documentum/Core Dossier Software). Validation of data transfer per ISO/EIC Guidelines.

1/1994 – 5/2001 CONTRACTOR/PM Small project contractor (decks, kitchen, bath, etc…) Entailing plumbing, electrical and carpentry. Utilized handyman/woman knowledge.

9/2001 – 5/2002 Consultant PROJECT MANAGER for private individuals within financial institutions utilizing my Business Development, Motivational Leadership qualities and Organizational Team-building effectiveness.

4/2001 - 7/2001 Arbour Group-PROJECT MANAGER Consultant

IT Software Development, Implementation/Completion Quality System mapping / triage for MediSense compliance with Abbott Diagnostic Division Quality System. Includes review/mapping of all Company Policies, Processes and Procedures according to CFR Title 21, Part 211, Part 820, Part 11 & ISO Certification qualifications. Timelines; Tracking; Quality System Review; Perf. Metrics; & Data Analysis etc... Training on BPCS software validation.

9/2000 - 4/2001 Med Focus-@Searle/Pharmacia - CLINICAL DATA MANAGER Final Review Team

Clinical Data Coding/Validation/Reconciliation of Serious Adverse Events, GCP’s & SOP’s of the following: DER MedWatch; ICD-9; WHO Drug coding; Safety Tables.

Review of Statistical Analysis Plan; & developing protocol specific database edit checks.

Liaison between site/client; statisticians, IT, and Clinical Research Organization.

Closing/Locking of a Global 1142 site, 13,274 patient Celebrex (Celecoxib) study for NDA.

1/2000 - 4/2000 Scirex Corp. - CLINICAL DATA COORDINATOR

Project Leader with review & audit of draft protocols, Case Report Forms, database structure, data entry and provide feedback. Compose data guidelines, entry manuals and other necessary documents. . Generate electronic queries to internal and/or external clients for resolution. Query/Resolution of discrepancies. Use multi-sponsor developed data management systems and policies, as required per protocols. Regulatory Affairs - Submissions of SAE’s, AE’s, & Safety Update FDA & HPB Reports.

9/1997 - 1/2000 Fujisawa Healthcare Inc. - CLINICAL DATA ASSISTANT

Develop; clinical database design, maintenance & software validation. Develop & update of data entry manuals, rules, SOP’s and data dictionaries per protocol. Tracking & editing CRF’s; review data for protocol & GCP compliance. Assist in the creation of clinical study database, specifications, design, development and validation of software application CRF Design (design, development and review). On protocol teams: Dermal, FK317, & Transplant studies etc…

9/1995 - 8/1997 Chicago. Park Dist & various companies- INDEPENDENT CONSULTANT

Implemented science curriculums and Instructed the Park Supervisors. Learning Center instructor & Computer Program Facilitator.

9/1995 - 8/1997 Grace Productions - DIRECTOR OF BUSINESS DEVELOPMENT: Chicago. Public School

After-school program science curriculum development.


7/1983 - 10/1984 Dr. Thomas E. Dolan - MEDICAL ASSISTANT / LAB MANAGER

6/1981 - 6/1983 Bethany Methodist Hospital - PHLEBOTOMIST / LAB ADMINISTRATIVE ASSISTANT

EDUCATION: 4/2017- Present Colorado Technical University (Graduation 12/2018 Summa cum laude)

Masters of Science in Homeland Security; Emergency Management and Public Health

3/2017 Colorado Technical University B.S. in Project Management (4.0 GPA)

Project Management Institute (PMI) Curriculum

5/1980 St. Scholastica Academy High School Diploma


Extensive pharmaceutical R&D certified training; Medical & Pharma Terminology Certificates

Dale Carnegie Seminar Competition - 1st PLACE Lead PM winner

Extensive computer training / skills (MS Word, Excel, Power Point, Access, EP90 Development, MS Project, Documentum Specialist, Visio, Argus, eCSD, Internet, et…)

Home Inspector Training (Oakton Community College)


Ability to communicate technical attributes personably to a sophisticated audience.

Highly analytical, conscientious of legalities, timelines, expenditures & keen attention to detail.

Diverse in procurement, SALES and as a TRAINER.

Coordinator of corporate Olympics for Fujisawa in the Parkway Athletic Club Olympics.

Surgical Assistant for a podiatrist (patient preparation, testing, vitals, observation and assistance during the procedure).

Strong sense of TEAMWORK with an EXTENSION OF PASSION.

Proficient on all MS Office programs, Visio and various IT Software.

Areas of expertise include: PM, Regulatory, Energy, Medicine (Western, Eastern, Ayurvedic,

Herbology, and Energy Medicine), International Relations, IT Software Development,

Business, Contract Law, Construction and Training Development/Implementation.

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