Senior Clinical Project Manager or Senior Clinical Trial Manager

KEY QUALIFICATIONS I am self-motivated, attentive to detail, organized and able to manage simultane ously multiple projects and activities. I have well-developed critical and anal ytical thinking skills and strong communication skills, both verbal and written. My adaptability and flexibility allow me to thrive in a dynamic workplace. I h ave a thorough understanding of the principles of clinical research from study s tart-up (GCP and SOPs) through execution and reporting. My professional experien ce spans more than twenty years of organizational and administrative leadership focused on client, contractor, and vendor relations and prioritization and manag ement of workflow. In over ten years in clinical research, my strengths includ e: a prioritizing workload and executing activities with minimal supervision a program-level coordination across multiple studies/teams a managing local monitoring team staff to meet deadlines/objectives a managing global clinical research offices, in-house study teams and external s ervice providers (vendor management, data management CROs) a meeting planning, preparation and execution a identifying, selecting and start-up of study sites a developing and executing contracts, team and site training, documents and proc esses EXPERIENCE Sr. Clinical Project Leader, Sanofi-Aventis, US, Inc.; Malvern, PA (CPL 6/05a" 1 /09, Sr. CPL 1/09 a" Present) As the Lead CPL of a group of four (4) CPLs working across a seven (7) study Typ e 2 Diabetes program, I am responsible for coordinating efficiencies. I ensure that the program-level information and training is consistent and updated as nee ded across studies, sites, and monitoring teams. Among my accomplishments in th is role, I: a Led the team in evaluating existing site/team training materials and implement ed a joint program training initiative (for CRAs and sites), parts of which were adapted for global use. a Implemented program-level dissemination of amendments, data management initia tives and safety elements for US & Puerto Rico sites and across teams a Facilitated global communications, when needed, from the US program team to en sure consistent responses across study teams a Interfaced directly with and managed study activities, including: a Central Vendors (IVRS, central lab, recruitment & retention) a Local, regional and global team members, including monitors, medical directors and data managers a Managed 5 direct reports (monitoring team members) including reviews and train ing a Planned and led several investigator (in US & Puerto Rico) and booster meeting s and lead monitoring team teleconferences on a monthly basis a Developed study tools (for CRAs & sites), training programs and tracking syste ms for coordination of trials, grants, enrollment status and clinical supplies a Reported study progress to global team members and ensured timelines and budge ts were met; developed study budgets for my assigned studies a Managed feasibility planning and start-up functions with in-house and field te ams a On a previous program, I participated on a Pre-Approval Inspection (PAI) team, and participated in global meeting preparation and presentation a Served as an Impact (Clinical Trial Management System) Super User to provide r outine support to users, and participate in new and refresher training as needed during deployment of upgraded versions. Sr. Clinical Research Scientist, AstraZeneca, LP, Wilmington, DE (3/04 a" 6/05)

Member of a CNS clinical study team who participated in set-up, management, exec ution and reporting of a global stroke trial, including: a Worked with a US CRO and non-US research units (called Marketing Companies) to facilitate site start-up and initiations a Managed Israeli CRO (TEVA) from contract negotiation, SOP training, selection of sites, global supply distribution, review and approval of ICFs, and other cli nical documents a Authored and reviewed ICFs for US and non-US use; managed study participation for 8 countries and trained new local and global team members a Managed day-to-day clinical interactions with Austria, Greece, Switzerland, & Israel, including SAE reporting, ensuring receipt of safety letters, and trackin g local ethics approvals for IP distribution a Managed study-wide, PK component (supply, set-up and tracking), and vendor sup plies (IVRS, central lab, central ECG reader, study web site), including local s tudy team documents and tools a Liaison between marketing company staff and local/ global study team members t o ensure communication and understanding of cross-country processes for efficien t conduct of study a Initiated and planned kick-off, training, and investigator meetings with local and global study teams, marketing company, site, and vendor participants (in th e US, Sweden & Switzerland) Clinical Research Scientist, AstraZeneca, LP, Wilmington, DE (1/02 a" 3/04) As a site monitor on a global study team for an osteoarthritis trial, I: a Conducted site selection, initiation, interim and close-out monitoring visits; wrote and reviewed visit reports, correspondence, telephone logs and other moni toring documents and managed day-to-day interactions with study sites a Interfaced directly with Data Management vendor for resolution of queries and other study data; reconciled remaining queries at all sites in preparation for D BL and closeout, including drug return forms; assured adequate reporting and doc umentation of adverse events, protocol deviations, and patient status; assured m aintenance of study and regulatory documentation, collected FDA documentation a Managed study drug return & reconciliation for all US study sites (57) a Participated in global clinical study report review and study-wide lessons lea rned meetings in the UK Clinical Coordinator, Rheologics, Inc., Exton PA (5/00 a" 11/01) (a medical devi ce company founded by cardiologist Dr. Kenneth Kensey to develop blood viscosity technologies) Initiated clinical program by choosing and managing the local C RO and engineering project team: a Coordinated efforts with CRO and site investigators to develop protocols, CRFs and ICFs a Managed study activities for trial preparation, including representing sponsor at initiation visits a Assisted engineering team in development and distribution of device operations and instruction manuals a Coordinated clinical budgets, contracts, and payments and was the primary spon sor manager for site staff and CRO staff a Managed sponsor attendance at American Heart Association (2000 & 2001) shows, including booth design, staffing and coordination of investigator dinners Project Director, Rheologics, Inc., Exton PA (4/99 a" 5/00) As a Project Director, I managed project tasks and clinical team for this medica l device company. Tasks included: a Managed CRO and other clinical subcontractors, including engineers, writers, a nd marketing/design vendors to coordinator flow of information, work product, an d timelines across multiple disciplines of a single medical device a Coordinated in-house personnel and consultants, including development of confi dentiality agreements and clinical site contracts a Supervised, edited and provided background material for written device documen

ts; managed publishing tasks for medical book and articles relate to device, lia ised between authors, editors and publisher a Planned, implemented and presented at site meetings, trades shows and contract or meetings (including hospital staff, investigators, and investors). a Worked with patent attorneys and sites to gather required patent documentation Property Manager, Edgehill Enterprises, Inc., Exton, PA (4/98 a" 4/99) Responsible for management of personal assets and business interests of several small businesses, including: a Vendor management (site contractors and various service vendors (pluming, elec trical, etc.) a Assisted in negotiations of vendor work orders and tenant leases a Coordinated tenant move-in/move-out including acquisition of permits, selectio n of contractors, site build-out, inspections and required documentation a Acted as a liaison between owner and tenants on issues pertaining to on-going and specialty maintenance. Additional work experience (5/87 through 4/98) available upon request. Education BA, Political Science, Gettysburg College, Gettysburg, PA, 1987 Software Excel, Word, PowerPoint, Outlook, Access, IMPACT, Clinical Trial Information (CT I), eCRF (ADAMS, the sanofi-aventis RDC package)