Sie sind auf Seite 1von 3

Gaetano Lardieri, MPM

Ironbound Village, Newark, NJ 07105 201-259-9164 Novorsch2k@aol.com www.linkedin.com/pub/glardierimpm SUMMARY Innovative Program/Project Management Professional with a broad spectrum of Healthcare/Oncology experience in conducting clinical trials in both hospital and pharmaceutical settings. Team leader who generates energy and excitement at both the international and sub-team levels to add value to any program/project. Recognizes opportunities to improve processes by implementing lean practices and methodologies to execute the mission and demonstrate passion for the corporate vision. Project Management Data Management Clinical Trial Management CRO Management Quality Management Process Improvement Lean Six-Sigma Practitioner Quality Improvement

EDUCATION/PROFESSIONAL DEVELOPMENT and COMPANY SPONSORED TRAINING Rutgers University Bachelor of Arts- Philosophy, Psychology, Social Work OPPMi One Page Project Management International MPM-Masters in Project Management Certification, May 2011 SIX-SIGMA Certifications 6-Sigma Overview/Lean/Muda Elimination (6-Sigma USA on-line Certifications) June, 2011 Six Sigma White Belt Certification-Vector International, June, 2011 Six Sigma Green Belt Certification-Red Cross Disaster Communication ToolVector September 2011 Management Certification, Becoming A Leader-Certification-Jack Welch-(MBA)-Institute-Chancellor University, July, 2011 Clinical, Data Management, Project and Team Management Extensive training in the areas of Clinical Research, Data Management, Project Management, and Global Team Management from PMI, Kendle, CfPIE, Kepner-Tregoe and other top-level organizations/vendors. PROFESSIONAL EXPERIENCE EISAI, Woodcliff Lake and Ridgefield Park, NJ 2004 - 2011

Senior Analyst/(Project-Process Manager) - Oncology (2009 - 2011) Appointed by the Oncology Unit President to manage three high level committees: Global Monthly Oncology Strategy and Planning Meeting (40%), Protocol Review Committee (15%), Disclosure Steering Committee (10%) and identify areas where improvements were needed for these areas and the Oncology Business Unit (35%). Worked with Project Managers, Team Leaders, and Clinical Leaders to prepare data for monthly meeting. Facilitated Global Monthly Oncology Meeting. Responsible for recording, summarizing/finalizing minutes and follow-up with International Team Leaders and other cross-functional team members on action items. Produced final meeting minutes and followed up with International Team Leaders and other cross functional team members on action items to ensure accuracy of minutes and completed action items. Improved consistency of reporting across teams by recommending uniformity of data presentation. Streamlined and improved resource planning review process for the Monthly Oncology meeting by developing an interactive web-based calendar which captured high level national/international agency meetings as well as major program and project milestones. Processed all protocols and amendments for review through the Protocol Review Committee. Reduced protocol review and approval time 50% by designing, implementing, monitoring, and maintaining tools to submit protocols and protocol amendments to the Protocol Review Committee. Led a 5-member cross functional team to process and register all oncology studies onto ClinTrials.gov. Achieved 100% compliance for registration of all studies for the Oncology Business Unit by designing, implementing, monitoring and maintaining a tracking tool for the Disclosure Steering Committee. Shortened timeline by more than 25% for the following processes: CSR, IB and DDP. Recognized with LEAD award by the Director of Medical Writing.

Gaetano Lardieri

Page 2

Project Manager - Oncology (2006 - 2009) Managed multi-functional international project teams for multiple Phase I and II studies which led to approval of Halaven in the USA, EU and Japan for the treatment of late-stage Metastatic Breast Cancer. Led International Project Team and collaborated with sub-teams to ensure milestones were met for all the Phase I and II studies which led to the submission. Anticipated project issues and developed contingency plans to avoid crisis management. Maximized communication through extensive follow-up and sharing of project task documents. Clinical Data Manager - Oncology (2004 - 2006) Managed/supervised all aspects/activities of in-house clinical trials as well as CRO run Clinical Trials for Phase I, II and III studies. Supervised 2 in-house direct reports. Reported to the Director of Data Management. Met all data management requirements/milestones: Protocol/CRF development, Database Design/ Testing/ Implementation, Edit Check creation, review of Lab Normal Ranges, AEs/SAEs, Con-Med. Coding, Patient Profile Review, Query generation/ resolution to ensure timely data cleaning and integrity. Developed and implemented department SOPs and first Data Management Manual.

PROFESSIONAL CONSULTING EXPERIENCE Independent consultant assigned through various agencies to apply Oncology expertise in Data Management, and Clinical Research to assist in achieving company objectives for studies and projects. PFIZER, Morris Plains, NJ 2002 - 2004

Records Management Science Associate Managed all aspects of records processing. This included receiving, tracking, properly verifying, identifying and archiving all business records from the clinical and regulatory groups into an electronic filing system. Reported to the Department Director. Served as lead for 3 consultants. Generated database reports for Quality Control. Developed document flow process and data tracking system in Excel for ease of future retrieval. Implemented Departmental SOPs and workflow processes to ensure quality control. Achieved timely clean-up of legacy studies vital to the companys portfolio. KENDLE, Cranford, NJ 2002

Senior Clinical Data Manager Performed daily Data Management related activities to support the needs of the Data Management Business Unit as well as several sponsors. Reported to the Director of Data Management. Reviewed/processed clinical trial data to ensure database accuracy and consistency. Tracked, reviewed validated CRFs and ensured proper med and AE coding. Advised junior Data Managers on resolution for clinical issues and questions. Met all goals/objectives of the Data Management Business Unit by timely and accurate review of data. SCHERING-PLOUGH RESEARCH INSTITUTE, Kenilworth, NJ 2001

CRA - Oncology Managed 10 sites in Latin America for data cleaning sweep for a Phase III Breast Cancer Study. Reviewed data for approximately 125 patients. Generated queries to resolve all data discrepancies. Communicated with sites to resolve data discrepancy issues. Updated CT-IV Database with Query Resolutions. Achieved Interim Analysis Milestone to support study trial decision. Recognized by the VP of Oncology (C. Tendler) for contribution to project objectives. MERCK PHARMACEUTICALS, Rahway, NJ 2000

Medical Program Coordinator - Pulmonary Managed hundreds of data files for data cleaning efforts for several Pulmonary studies. Reviewed International/Domestic data tables for accuracy and outliers. Reviewed Regulatory and TMF documents and Drug supply documents for completeness and accuracy.

Gaetano Lardieri PFIZER PHARMACEUTICALS, New York City, New York

Page 3 1999 - 2000

CRA Consultant - CNS Managed Data Query resolution of DCFs between CRO and sites. Reviewed data for discrepancies for studies in close-out phase. Coordinated resolution of DCFs between CRO and sites. Assisted other Project Managers in various clean-up tasks for various studies. NOVARTIS PHARMACEUTICALS, Summit, NJ 1997 - 1999

Clinical Data Manager - Oncology Managed 5 Sites/CROs for various studies over a two-year period and managed the work of 5 Clinical Data Assistants. Resolved data discrepancies through written and telephone contact with sites. Represented Data Management at team meetings and Validation and Planning Meetings. Received Ovations Above & Beyond Award from Director for meeting Data-Management Milestones. Received Project Letter-of-Appreciation from D. Parkinson MD VP Oncology for reaching Interim-Analysis Milestone. SCHERING-PLOUGH RESEARCH INSTITUTE, Kenilworth, NJ CRA - Oncology Managed several International sites for a Leukemia study in close-out phase. Reviewed data for clinical accuracy. Generated/resolved queries for data discrepancies. 1997

SAINT BARNABAS HEALTH CARE SYSTEMS, Livingston, NJ 1985 - 1997 Clinical Site Coordinator - Cancer Center (1994 - 1997) Coordinated with the entire Oncology staff and 9 Principal Investigator Oncologists, to identify/randomize Oncology Patients to various inter-group and Pharmaceutical Sponsored Clinical Trials. Research Assistant - Dept. of Medicine (1992 - 1994) Collaborated with Oncologists, Gastroenterologist, Gastric Surgeons, GI Endoscopy Nurses, Geneticists and BioStatisticians to identify patients and families for participation in the Genetic Epidemiology Polyp Study. Unit Coordinator - Dept. of Nursing (1985 - 1992) Partnered with all medical personnel to bring quality care to Patients in Oncology, Medical and Surgical units. TECHNICAL SKILLS MS Project, Documentum, Primavera, QuickBase, Oracle Clinical, Clin-Trials, Office 2010 (Word, Excel, PowerPoint) Lotus Notes, VISIO PROFESSIONAL ORGANIZATIONS ISSP PMI ASQ ACRP SCDM SOCRA International Society Six-Sigma Professionals Project Management Institute American Society for Quality Association of Clinical Research Professionals Society of Clinical Data Managers Society of Clinical Research Professionals PATENTS / PUBLICATIONS / ABSTRACTS Portable Reflexology Chair Suture-less Surgical Drain US Patent 6,755,463 Awarded 29-June-2004 Application 61/179,081

Zauber, Peter, Lardieri, Guy, Bishop, Timothy, (Oct. 1999). Site Specificity of Colorectal Neoplasms without an Inherited Syndrome. American Society of Gastrointestinal Endoscopy. Houghton, JeanMarie, Lardieri, Gaetano, Zauber, Peter, Kim Kyung, (May 2000).Effect of Cholesterol Levels on Villous Histology in Colonic Adenomas.Digestive Diseases and Sciences. Houghton, Jean-Marie, Lardieri, Gaetano, Zauber, Peter (Oct. 1995). Association of Serum Cholesterol Levels and Recurrence of Colonic Polyps. Abstract submitted and accepted for the 60th Annual Scientific Meeting American College of Gastroenterology October 16-18, 1995, New York, New York

Das könnte Ihnen auch gefallen