Project Manager Management

Gaetano Lardieri

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GAETANO LARDIERI, MPM

973-***-**** • **********@***.*** • http://www.linkedin.com/in/gaetanolardieri

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. Recognized for consistent process improvement 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

* Motivational Team Leader

* Quality Improvement

* Lean Six-Sigma Practitioner

Professional Experience

Covance Clinical Development Services, Princeton, New Jersey – Feb. 2012 – April 2014

Manager, Project Integration, Clinical Data, Analysis, & Reporting Org. – Feb. 2012 – April 2014

* Provide project management support to Data Management, Statistics, Statistical Programming, and Medical Writing groups for Phase II-IV clinical studies.

* Coordinate the modeling of CDARO operational tasks, project timelines/milestones, and production of deliverables with an awareness of dependencies and risks to successful service delivery.

* Participate in Sponsor and internal project team meetings and training sessions.

* Interface with internal and Sponsor project management and CDARO management on operational issues.

* Collaborate with Sponsors on the establishment and enhancement of operational processes and roles/responsibilities in preferred-provider relationships.

Forest Labs, Jersey City, New Jersey – Nov. 2011 – Feb. 2012 Project Manager, Scientific Assessments – Nov. 2011 – Feb. 2012

* Evaluated candidate drugs for in-licensing based on scientific merit.

* Identified review teams to assure relevant functional representation.

EISAI, Woodcliff Lake and Ridgefield Park, New Jersey – Jun. 2004 – May 2011 Senior Analyst/Project-Process Manager, Oncology – Jul. 2009 – May 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%), and Disclosure Steering Committee (10%) to 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 meetings.

* Facilitated the Global Monthly Oncology Meeting where he was responsible for recording, summarizing/finalizing minutes, and follow-up with International Team Leaders and other cross-functional team members on action items.

* Streamlined and improved the 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 five-member cross functional team to process and register all oncology studies on 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.

Project Manager, Oncology – Jul. 2006 – Jul. 2009

* Managed multi-functional international project teams for multiple Phase I and II studies which lead to approval of HalavenTM in the USA, EU, and Japan for the treatment of late-stage metastatic breast cancer.

* Led the International Project Team and collaborated with sub-teams to ensure milestones were met for all of 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 – Jun. 2004 – Jul. 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 two in-house direct reports.

* 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, and query generation/resolution) to ensure timely data cleaning and integrity.

* Developed and implemented department SOPs and the first Data Management manual.

Pfizer, Morris Plains, New Jersey – Sep. 2002 – Jun. 2004 Records Manager – Sep. 2002 – Jun. 2004

* 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.

Kendle, Cranford, New Jersey – Sep. 2001 – Sep. 2002 Senior Clinical Data Manager – Sep. 2001 – Sep. 2002

* Performed daily data management related activities to support the needs of the Data Management Business Unit as well as several Sponsors.

Schering-Plough Research Institute, Kenilworth, New Jersey – Jan. 2001 – Aug. 2001 Clinical Research Associate, Oncology – Jan. 2001 – Aug. 2001

* 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 and query resolutions.

Merck Pharmaceuticals, Rahway, New Jersey – Jun. 2000 – Nov. 2000 Medical Program Coordinator, Pulmonary – Jun. 2000 – Nov. 2000

* 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.

Pfizer Pharmaceuticals, New York City, New York – Oct. 1999 – Apr. 2000 Clinical Research Associate, CNS – Oct. 1999 – Apr. 2000

* 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, New Jersey – Sep. 1997 – Sep. 1999 Clinical Data Manager, Oncology – Sep. 1997 – Sep. 1999

* Managed five sites/CROs for various studies over a 2-year period and managed the work of five Clinical Data Assistants.

* Resolved data discrepancies through written and telephone contact with sites.

Schering-Plough Research Institute, Kenilworth, New Jersey – Jun. 1997 – Sep. 1997 CRA, Oncology – Jun. 1997 – Sep. 1997

* Managed several international sites for a leukemia study in close-out phase.

* Reviewed data for clinical accuracy.

St Barnabas Health-Care Systems - 1994 – 1997 (3 years)Livingston, N.J.

Site Coordinator – Oncology

Site Coordinator – Cancer Center

* Coordinated with entire Oncology staff and 9 Principal Investigator Oncologists, to identify/randomize Oncology Patients to various inter-group and Pharmaceutical Sponsored Clinical trials.

* Instrumental in developing the Cancer Center's first Site-Coordinator position.

St Barnabas Health-Care Systems - 1992 – 1994 (2 years) Livingston, N.J.

Research Assistant Oncology

Research Assistant – Department of Medicine

* Collaborated with Oncologists, Gastroenterologists, Gastric Surgeons, GI Endoscopy Nurses, Geneticists and Bio-Statisticians to identify patients and families for participation in the "Genetic Epidemiology Polyp Study."

* Interviewed over 3,500 patients and family members for participation in this study.

* Identified over 100 kindreds that were appropriate for the study.

* Co-authored several Abstracts and Articles for Scientific journals and conferences.

Therapeutic Experience

* Oncology

* CNS

Education

* Bachelor of Arts degree, Philosophy, Psychology, and Social Work, Rutgers University, Newark, New Jersey

* Project Management Certification, Masters in Project Management, American Academy of Project Management

* Business Management Certification, Becoming a Leader, Jack Welch Management Institute, Chancellor University

* Six Sigma Certification, Overview/Lean/Muda Elimination, 6-Sigma USA

* Six Sigma Certification, White Belt, Vector International

* Six Sigma Certification, Green Belt, Vector International

Memberships/Awards

* International Society of Six Sigma Professionals

* Project Management Institute

* American Society for Quality

Appendix I

Publications and Abstracts

Publications

Houghton, J., Lardieri, G., Zauber, P., and Kim, K., “Effect of Cholesterol Levels on Villous Histology in Colonic Adenomas,” Digestive Diseases and Sciences, 2000.

Zauber, P., Lardieri, G., and Bishop, T., “Site Specificity of Colorectal Neoplasm's without an Inherited Syndrome,” American Society of Gastrointestinal Endoscopy, 1999.

Abstracts

Houghton, J., Lardieri, G., and Zauber, P., “Association of Serum Cholesterol Levels and Recurrence of Colonic Polyps,” 60th Annual Scientific Meeting of the American College of Gastroenterology, October 16-18, 1995, New York, New York.

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