CHARLENE FIELDS 1550 Muhlenburg Drive Blue Bell, PA 19422 Home: 484.231.8668 cf116ec44@westpost.net Mobile: 215.500.

8436 SUMMARY OF QUALIFICATIONS - Proficient and highly organized Project Manager experienced with simultaneousl y leading cross-functional study teams in the delivery of quality processes, del iverables and Electronic Data Capture (EDC) applications for clinical trials thr ough a full project life cycle. - Accomplished Study Designer, Clinical Data Analyst and Lead Data Manager with more than six years experience with In-House & EDC applications for various drug phases and therapeutic compounds. Experience including but not limited to: the design and development of eCRFs, discrepancy management and validation rules cre ation. - Self-motivated and performance driven leader focused on cultivating quality an d excellence. CORE COMPETENCIES EDC Applications (Medidata Rave, Oracle Clinical, PhaseForward Inform) CDISC SDTM Standards/Mapping Clinical Trial Management Systems/ Interactive Voice Response System (IVRS) Quality Assurance Protocol Development Vendor Management Designing CRF/eCRFs Query Management Training and Mentoring Managing Multiple Projects Simultaneously. Organizing and Directing Cross-Functional study teams Knowledgeable of the Project Management lifecycle

PROFESSIONAL EXPERIENCE ACCENTURE at MERCK - Blue Bell, PA April 2010 - Present Senior Specialist-CDM-Study Project Manager Manage multiple studies to production (some earlier than planned/baselined) with exceptional quality and adherence to process. Accomplished by effectively organ izing and directing quality work efforts of the study team; driving out frequent clear and action driven communications that alerts all client team members to t he risk present if tasks are not done on time by cross functional teams as well as taking an aggressive stance on delivering the database based on what is right rather than only on a time line and having to make changes post production. Operations - Responsible for developing program/project plans and estimates for end to end program/project management, scoping and requirements through implementation and deployment. - Proactively monitor and manage execution of deliverables. - Serve as the single point of contact for the client at a study level as well a s holding accountability for predictable, timely and high quality delivery acros s all functional areas. Project/Phase Planning and Estimating - Develop study project plans and estimates through collaborations with MACH1 st

udy project team members and negotiations with the client - Determine needed deliverables, overall project schedule/timeline, critical pat h by deliverable, productivity improvements, overall risks and planning assumpti ons - Drive/evaluate estimates by deliverable and work with teams to optimize overal l estimates - Ensure that all study project team members as well as clients are well-informe d of the plan and committed to support End to End Phase/Project Management - Manage the project for its entire duration from protocol approval to final arc hiving. - Proactively manage and monitor execution of deliverables and status in an asse rtive manner - Closely monitor the project progress and proactively identify risks/issues - Determine impact of risks/issues and facilitate resolutions as necessary - Escalate issues to functional team leads/management which cannot be resolved a t the study level - Manage critical path, dependencies, contingency, and scope/change requests - Manage Change Requests, validate impacts, and ensure study project members are appropriately consulted and informed. - Eliminate road blocks, proactively, in the critical path to help ensure succes sful delivery of the solution - As a single point of contact, report and manage overall study project status t o the client and ensure that their expectations are understood and managed appro priately. - Liaise with other shared service teams (external data, SDTM) to ensure all nec essary components are in order - Validate that proper deliverable and phase stage containment is occurring (e.g ., signoffs are scheduled and completed, dependent deliverables are completed, n ecessary client approvals are obtained, a study member who takes the next course of action is properly informed/cued, etc.,) - Find common grounds, proactively share information and ensure proper and regul ar communication takes place across all functional team members. - Proactively ensure that a study project team is in compliance with internal pr ocesses, quality reviews, SLAs, metrics, and timelines ACCENTURE at MERCK - Blue Bell, PA January 2008 - Present Senior Specialist-CDM-Study Designer Operations - Managed the end to end delivery of Electronic Data Capture (EDC) applications to ensure they are developed in accordance with standard business processes and meet client requirements. - Functioned as a Clinical Trial Management Systems (CTMS) owner and study matte r expert in conjunction with Interactive Voice Response System (IVRS) - Worked with onshore resources including project managers and other functional departments during the initial specification and Final User Acceptance Testing ( UAT) of EDC applications for clinical studies including custom reports and clini cal outputs. - Worked with offshore resources including Study Build Lead and Reports Developm ent Lead during development and Quality Control (QC) testing of EDC applications . - Coordinated and managed the delivery of up to 5 study databases at a time usin g the PhaseForward Inform EDC software and related Merck standards and processes . - Created detailed CRF/eCRF specifications for the development of EDC screens. - Created SDTM mapping specifications for EDC data fields. - Developed edit check specifications for EDC application - Developed the Data Review Plan and created study specific Data Entry and Handl

ing Guidelines. - Coordinated User Acceptance Testing of EDC applications and reports. - Functioned as a Clinical Trials Management Systems (CTMS) owner and study matt er expert. - Served as a project point of contact for Study Build Resources, QC specialists , and reporting specialists providing detailed setup and configuration knowledge and expertise. Project Management - Prepared, maintained and finalized project plans for delivery of all specifica tions provided by Merck. - Ensured offshore functions were aligned to meet Project Management timelines a nd deliverables - Assisted in the scheduling of offshore resources and ensured timely completion of deliverables. - Liaised with other shared services teams (e-data vendors, form production) to ensure all components needed for accurate and complete study design are complete d as needed. - Planned work effort using project planning tools including the MS Project Plan s and the Accenture Service Management System (SMS) for resource allocation and utilization. - Managed the plan within the teams by proactively identifying and communicating relevant changes as well as identifying risks and managing risk mitigation. - Collaborated with and liaised between the clinical study teams of the client a nd our working teams in our offshore facility building the deliverables. INC Research - Hatboro, PA November 2006 - January 2008 Clinical Data Analyst II/Lead Data Manager Study Data Management: - Managed multiple projects at various stages of development through production. - Developed/reviewed Case Report Forms and review against protocol for data cons istency. - Developed and implemented study-specific Clinical Data Management Plans to mee t sponsor specifications. - Reviewed study-specific database design specifications created by Clinical Pro grammer. - Wrote functional specification for electronic edit checks and quality control listings. - Prepared test data for User Acceptance Testing of database screens and edit ch ecks. - Performed User Acceptance Testing and validation of data entry screens and ele ctronic edit checks for functionality of the database along with accurately reco rds issues. Project Management: - Worked closely with Project Manager and Sponsor to develop timelines, review b udgets and contracts and finalize project requirements. - Monitored timelines to ensure all deadlines were met and key milestones delive red on time. - Proactively communicated with sponsors, internal and external project manageme nt teams and programmers. Global Employment Solutions at PharmaNet - Blue Bell, PA July 2006 - November 20 06 Clinical Data Analyst Study Data Management: - Performed data review and query generation; Defined edit checks to be programm ed for the study/project; Reviewed programmed edit checks; Tracked study progres

s and issued periodic status reports. - Created and resolved (as appropriate) data queries. - Created and resolved coding queries based on a coding report from the sponsor. - Performed data listing reviews and updated tracking systems as necessary. - Created and maintained study files and appropriate study documentation. - Participated in quality control measures necessary for finalization and transf er of database to sponsor. Michael Fladger and Associates at Merck - Blue Bell, PA April 2004 - January 200 6 Assistant Data Management Specialist Study Data Management: - Supported the design and development of Data Management activities of drug and vaccine development - Applied Data Management expertise and computer skills in support of Data Manag ement activities of drug and vaccine development - Interpreted and applied data handling and entry guidelines concurrent with ent ering, verifying and correcting data to meet clinical timelines in support of dr ug development programs - Identified and reported issued related to data collection to the appropriate t eam members - Defined, designed, and validated data collection tools, data queries, final re ports and files. - Managed non-case report forms (CRF) clinical data - Generated Discrepancy Notification Forms (DNF) for Data Review - Evaluated and applied DNF's for drug and vaccine trials and development - Performed general Data Entry and Data Review tasks in support of Data Manageme nt - Served as a Mentor for Data Entry tasks (evaluated/proofed CRF's and performed QC) - Interacted and worked closely with members across functional areas both within as well as outside of the Data Management Operations department. - Supported the design and development of Data Management activities of drug and vaccine development - Performed departmental activities to assist in workload tracking and overall m etrics CERTIFICATIONS Currently Pursuing Project Management Institute, Inc. - Philadelphia, PA Project Management Professional (PMP) October 2008 - October 2009 Keller Graduate School of Management - Philadelphia, PA Graduate Certificate in Project Management EDUCATION September 2007 - October 2009 Keller Graduate School of Management - Philadelphia, PA Masters of Business Administration

August 1997 - May 2001 Lincoln University - Lincoln University, PA Bachelor of Science in Computer Science TECHNICAL SKILLS Clinical Trial EDC Systems: Medidata Rave, Oracle Clinical, PhaseForward Inform High Proficiency: MIDAS Documentum, MS Project 2007, SharePoint Services (TeamSi te), PowerPoint, Access, Excel, Word, Windows NT, Documentum Version Control Uti lity, CRF WorkManager 4.2, CTMS (Clinical Trial Management Systems), Visual CACT US, CISCO Call Manager, FACS Collection System, Interactive Voice Response Syste m (IVRS), MedDRA

THERAPEUTIC AREA EXPERIENCE Atherosclerosis Arthritis/Osteoarthritis Arthritis and Immunology Anti-Infectives Bone and Endocrine Cardiovascular HIV Infectious Disease Neurosciences - Neurology/Pain/Psychiatry Obesity Oncology Respiratory and Allergy Vaccines PROFESSIONAL AFFILIATIONS 2008 - Present Project Management Institute, Member 2008 - Present Project Management Institute, DVC (Delaware Valley Chapter) Member