Project Manager Quality Assurance
Resume:
Elizabeth Alex-Nosagie
Kennesaw GA 30144
Summary
Clinical Research professional experienced with database maintenance related to the management of Clinical Trials. Currently, a Project Manager supporting laboratory safety and efficacy testing for clinical trials, assisting with patient recruitment, liaising with Sponsor, Clinical Research Organization contacts and Quintiles Laboratories facilities locally and globally.
Formal Educational History
Last Date Attended Institution Name, Country Education Level/Degree Area of Study Completion Status
University of Georgia, United States BA Speech Communication Completed
Employment History
Quintiles Employment History
Date of Employment: 10/2009 - Present
Job Title: Project Manager
Key Responsibilities: Primary contact for Sponsors throughout duration of the clinical trial. Coordination of project initiation in conjunction with Set-Up Management team and Sponsor. Responsible for monitoring adherence to protocol requirements and protocol-specific timelines.
Date of Employment: 07/2008 - 10/2009
Job Title: Clinical Trials Assistant
Key Responsibilities: Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
Assist with periodic review of study files for accuracy and completeness
Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
May perform assigned administrative tasks to support team members with clinical trial execution.
Utilize InnTrax/InFormatics to monitor flow of documents
Date of Employment: 06/2007 - 07/2008
Job Title: Project Coordinator
Key Responsibilities: Responsible for assisting the Project Manager in coordination and management of studies within the Project Services Department; Responsible for performing monitoring on the Project Manager’s behalf and acting as primary contact in the Project Manager’s absence.
Non-Quintiles Employment History
Date of Employment: 11/2005 - 03/2007
Name of Employer: Think Resources, Inc
Job Title: Technical Recruiter
Key Responsibilities: Worked as a Recruiter to fill Technical positions for Fortune 500 clients domestically and internationally.
Responsible for sourcing candidates, screening resumes, scheduling interviews, negotiating offers and using relational skills with clients and candidates.
Averaged 3 placements per month and 40 calls daily.
Responsible for Recruiting a diverse group of candidates including and not limited to: Civil Engineers, Structural Engineers, Project Engineers, Quality Assurance Managers, Accountants, Plant Operators and Software Programmers.
Date of Employment: 12/2004 - 07/2005
Name of Employer: Walt Disney World
Job Title: Professional Recruitment Coordinator
Key Responsibilities: Worked as part of a team of three Coordinators that supported the recruiter team with hiring all salaried roles for Walt Disney World.
Coordinated interviews, itineraries, hotel, flight and rental car reservations for external Professional Recruitment candidates, requiring the ability to multi-task in a fast-paced environment.
Coordinated the new hire arrival process and facilitation of new hire orientations.
Supported all levels of leadership within the Operations, Entertainment and Animal Programs lines of business.
Responsible for all SAP and Personic system input including hires, rehires, and transfers.
Assisted the Leadership Casting Call process (front-line leadership candidate pool) for several operating areas.
Partnered with hundreds of candidates from four large Leadership Casting Calls which involved:
• Partnering with all levels of WDW hiring leaders to complete candidate approvals within a two-week deadline.
• Scheduling interviews and background checks for all supported candidates who were moving forward with the application process.
Clinical Trial Experience
Quintiles Clinical Trial Experience
Study Phase: Phase 3
Indication: Other
# of Countries: 1
# of Sites: 90
# of Patients: 600
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Oncology
# of Countries: 5
# of Sites: 28
# of Patients: 750
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Cancer - Colorectal
# of Countries: 5
# of Sites: 37
# of Patients: 675
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Oncology
# of Countries: 6
# of Sites: 30
# of Patients: 600
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: CABG
# of Countries: 6
# of Sites: 32
# of Patients: 600
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Oncology
# of Countries: 6
# of Sites: 30
# of Patients: 570
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Epilepsy
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Oncology
# of Countries: 6
# of Sites: 30
# of Patients: 570
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Oncology
# of Countries: 1
# of Sites: 8
# of Patients: 80
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Oncology
# of Countries: 6
# of Sites: 32
# of Patients: 600
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Multiple Sclerosis
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Oncology
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Asthma
# of Countries: 3
# of Sites: 9
# of Patients: 264
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Oncology
# of Countries: 1
# of Sites: 5
# of Patients: 12
Role: Project Manager
Key Responsibilities: Project Manager
Study Phase: Phase 2
Indication: Diabetes - Type II
# of Countries: 6
# of Sites: 155
# of Patients: 2520
Role: Project Manager
Key Responsibilities: Project Manager
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