Project Manager Quality Control

John J. Lucas

*** ******** ** *********, ** *****

215-***-**** • Email: ***********@*****.***

OBJECTIVE:

Achieve a Full time position within a Pharmaceutical or Biotech company.

SKILLS

Proficient with computer software: Microsoft Windows, MS Excel, MS Word, MS Power Point, Adobe PhotoShop, Oracle Clinical, InForm capabilities

WORK HISTORY

1/2007 – 4/2010 Accenture: Blue Bell, PA

STUDY DESIGNER – MERCK

Manage the end to end delivery of Electronic Data Capture (EDC) applications using InForm to ensure they are developed in accordance with standard business processes, and meet client requirements.

Work with onshore resources including Design, Develop and Deliver (3D) client team members, project managers and other functional departments during the initial specification & final User Acceptance Testing (UAT) of EDC applications for clinical studies, including custom reports and clinical outputs. Work with offshore resources including Study Build Lead and Reports Development Lead during the development and Quality Control (QC) testing of EDC applications for clinical studies, including custom reports and clinical outputs. Work with Clinical to performed protocol review, risk assessment, and develop study management plan. Plan and manage timelines and work effort using project planning tools including the MS Project Plans and the Accenture Service Management System (SMS) serve as a project point of contact for study build resources, QC specialists, and reporting specialists providing detailed setup and configuration knowledge and expertise. Served as project manager team lead managing 8-12 project managers, assigning all workload, giving performance evaluations, and running regular staff meetings.

8/2003 – 1/2007 Accenture: Collegeville, PA

STUDY DESIGNER – WYETH

Responsible for all aspects of GCD database build including data object configuration and validation documentation using Oracle Clinical software. Develop Case Report Forms (CRFs) with protocol specific content modification based on Global Library and Therapeutic area standards in preparation for the Analysis and Database Design (ADD) meetings. Liaise with Wyeth Clinical, Clinical Programming, Kineticist and other study team members to resolve CRF design, validation, database and OC view issues.

2/2000 – 8/2003 Wyeth Pharmaceuticals: Collegeville, PA

CLINICAL DATA COORDINATOR

Responsible for performing clinical data handling functions to build final data files for clinical trials. Ensure data quality and completeness and obtain proper documentation of data modifications using CDM processes. Organize and manage work distribution and perform special supportive functions. Report progress routinely to assure release of files to meet project goals. Commit to the CDM team environment and its goals by demonstrating open communication and a strong collaborative work ethic.

EDUCATION:

1993 – 1997 Delaware Valley College: Doylestown. PA

BS – Biology

BS in Biology with concentration in the Animal Biology field

REFERENCES

References furnished upon request

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