Sr. Project Manager, Global Clinical Supplies
Washington D.C. Metro Area
Clinical Supplies Project Manager with over 14 years Clinical Research experience in academic, CRO and pharmaceutical/biotechnology settings. Successfully manage projects from set-up to closure; meet performance metrics including trial timeline, financial targets, resourcing, and satisfactory mitigation of risks. Diverse skills set also includes expertise in Study Start-Up, Trial Master File (TMF); on-site Project Management; and Data Management...
Clinical Supplies Project Manager with over 14 years Clinical Research experience in academic, CRO and pharmaceutical/biotechnology settings. Successfully manage projects from set-up to closure; meet performance metrics including trial timeline, financial targets, resourcing, and satisfactory mitigation of risks. Diverse skills set also includes expertise in Study Start-Up, Trial Master File (TMF); on-site Project Management; and Data Management & Analysis (SAS). Creative, analytic-minded thinker able to bring new solutions to the table.Sr. Project Manager, Global Clinical Supplies @ From April 2015 to Present (7 months) Clinical Logistics Leader @ • Provide project financial and timeline management for contracts valued at nearly $10M • Work with internal team to ensure partnership client satisfaction • Manage depot, courier, central lab, and other vendor services • Market clinical logistics services at Sponsor Kick-Off Meetings and provide training at Investigator Meetings • Manage all aspects of the CLS New Hire Orientation training program, a 12 course sequence, 2011-2013 • Instructor for PAREXEL Academy, a Postgraduate Certificate Program in Clinical Trial Management, Summer 2012 From January 2011 to March 2015 (4 years 3 months) Decentralized MA (Located in Alexandria, VA)Clinical Logistics Specialist / Senior Specialist @ • Manage the global distribution of clinical trial supplies following GxP/ICH requirements • Establish process efficiencies including preferred-vendor cold chain shipping rates • Provide study drug forecasting, labeling and expiry date management; IVRS specification development; and cold chain shipping needs From May 2010 to January 2011 (9 months) Billerica, MAIn-House Clinical Research Associate @ • Collect all site regulatory documents for clinical trials from study startup to closure, ensuring GCP/ICH standards are met • Identify and resolve regulatory issues by working closely with sites, Clinical Trial Managers and on-site CRAs under deadline • Manage Trial Master File (TMF) review & reconciliation for final archival of audit-ready files From October 2008 to May 2010 (1 year 8 months) Cambridge, MAClinical Project Manager @ • Manage National Institute of Health (NIH) and pharmaceutical trials, from start-up to closure • Perform study budget and third-party vendor oversight • Drive patient recruitment plan • Oversee study conduct team and designed tracking system for patient visits • Write and revise study protocols, informed consent forms, and DSMB submissions • Prepare IRB submissions, adverse event reporting, and NIH progress reports • Complete case report forms (CRFs) during patient visits • Ensure study drug accountability and biological sample collection are in compliance with GxP/ICH • Prepare for and participate in site audits From May 2006 to October 2008 (2 years 6 months) Division of Rheumatology, Boston, MAClinical Project Associate @ • Direct all close-out activities for a multi-site clinical trial funded by the Agency for Healthcare Research and Quality (AHRQ) • Supervise team performing source document verification checks (data clarifications) of electronic CRF data • Manage budget issues and ensure final payments are made to all sites • Prepare IRB submissions • All close-out activities were complete and dataset ready for analysis by September deadline From January 2003 to September 2005 (2 years 9 months) Center for Clinical Trials & Evidence-based Health Care, Providence, RIData Analyst @ • Prepare research results for publication: tables, graphs, and analytic descriptive commentary • Conduct data analyses, perform literature searches and write literature reviews • Prepare a large, longitudinal and nationally representative dataset for multiple analyses using SAS • Prepare a clinical trial dataset for public use • Develop data clarification forms (DCFs) and drive query resolution From September 1999 to May 2001 (1 year 9 months) Institute for Social Research, Ann Arbor, MIData Analyst @ • Co-author of substance use profiles for each of the 50 states • Develop substance abuse indicators of alcohol, tobacco & other drug use • Supervise team creating multi-year Excel tables & graphs • Analyze drinking & driving data, write literature review, and present work at a national conference; work subsequently developed into publications From January 1997 to May 2001 (4 years 5 months) Policy Research on Women & Drugs Project, School of Social Work, Ann Arbor, MIM.P.H., Public Health @ University of Michigan From 1995 to 1997 Medical Coursework @ Brown University From 2005 to 2006 Post-Baccalaureate Pre-Medical Certificate @ Bryn Mawr College From 2001 to 2002 B.A., Anthropology and African Studies @ University of Michigan Laura Wheeler, MPH is skilled in: Project Management, Cross-functional Team..., Communication Skills, Project Finance, Supply Chain Management, Critical Thinking, Training Delivery, Third Party Vendor..., IVR, Creative Solutions, Analytical Skills, Clinical Study Design, GCP, Pharmaceutical Industry, CRO, CTMS, EDC, Clinical Development, Clinical Research, Clinical Trials, Data Management, FDA, Oncology, SOP, Logistics Management, Team Leadership, Biotechnology, Peer Mentoring
Sr. Project Manager, Global Clinical Supplies
April 2015 to Present
Clinical Logistics Leader
January 2011 to March 2015
Decentralized MA (Located in Alexandria, VA)
Clinical Logistics Specialist / Senior Specialist
May 2010 to January 2011
In-House Clinical Research Associate
October 2008 to May 2010
Tufts Medical Center
Clinical Project Manager
May 2006 to October 2008
Division of Rheumatology, Boston, MA
Brown Medical School
Clinical Project Associate
January 2003 to September 2005
Center for Clinical Trials & Evidence-based Health Care, Providence, RI
University of Michigan
September 1999 to May 2001
Institute for Social Research, Ann Arbor, MI
University of Michigan
January 1997 to May 2001
Policy Research on Women & Drugs Project, School of Social Work, Ann Arbor, MI
What company does Laura Wheeler, MPH work for?
Laura Wheeler, MPH works for PPD
What is Laura Wheeler, MPH's role at PPD?
Laura Wheeler, MPH is Sr. Project Manager, Global Clinical Supplies
What industry does Laura Wheeler, MPH work in?
Laura Wheeler, MPH works in the Pharmaceuticals industry.
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