SUMMARY Skilled professional with over eighteen years of experience in pharmaceutical and diagnostic clinical research management in the areas of hepatitis, HIV, depression, bipolar disorder, diabetes, anesthesia, women's health, and insomnia. Specialties: CRO Management, IVRS, EDC, Timeline Development, Budget Development, Laboratory, Advertising, Investigator Meeting Planning, Advisory Boards, NDA Filings, Mentoring, Monitoring

Senior Clinical Study Manager (Current Contract) @ Provide oversight of all clinical activities for Phase III/IIIb clinical studies in subject with Major Depressive Disorder and Bipolar I Disorder. Responsibilities include generation and adherence to timelines; oversight of clinical CRO; providing training of monitoring staff; providing all study information and tools necessary to ensure successful site level execution; data review; oversight of document management personnel; and co-monitoring of study sites. Performed under minimal supervision; position is home based. From October 2008 to Present (7 years 3 months) Independent Clinical Consultant @ From May 2000 to Present (15 years 8 months) Contract Project Manager @ Manage Phase III clinical study in subjects with Major Depressive Disorder. Responsibilities include management of clinical, data management, laboratory, IVRS, advertising and ECG vendors; leading internal multidiscipline study team meetings routinely; planning and execution of Investigator Meeting, CRA Trainings and Vendor Kickoff Meetings; protocol and ICF design and development; EDC development and implementation; clinical supplies planning; and co-monitoring of study sites. From November 2007 to October 2008 (1 year) Contract Project Manager @ Managed three women's health clinical studies from inception including one Phase I PK trial, one Phase II study and one international Phase III cardiac and breast cancer safety study. Responsibilities included protocol and ICF development; preparation of FDA submissions and responses; FDA meeting participation; Investigator Meeting planning and execution; clinical supplies management; vendor proposal acquisition/analysis/selection; management of clinical, laboratory, data management, advertising and IVRS vendors; site selection; prestudy and routine monitoring visits; and site/vendor contract and budget negotiations. From February 2007 to November 2007 (10 months) Program Manager @ Managed operations of a Phase I - III $200M global clinical program for an investigational diabetes product. Responsibilities included management of six study managers; timeline and budget planning and adherence; preliminary NDA preparations; integration of Takeda Europe into program according to company restructure; and implementation of program improvements in patient recruitment and mentoring of study managers. From September 2006 to February 2007 (6 months) Contract Project Manager @ Managed clinical studies for an insomnia product from Phase II through NDA and into Phase IV, including special population studies in COPD and elderly subjects. Phase II, Phase III and Phase IV responsibilities included creation and maintenance of study timelines and budgets; management of clinical, data management, laboratory, IVRS, advertising and niche (posturography, polysomnography) vendors; leading internal multidiscipline study team meetings routinely; planning and execution of multiple Investigator Meetings, CRA Trainings and Vendor Kickoff Meetings; protocol design and development; Advisory Board Meeting planning and execution; IVRS design for diary and medication management; EDC development and implementation; clinical supplies planning; extensive co-monitoring of study sites; study database closure and study report review; and participation in NDA filing activities including integrated efficacy and safety summary reviews and slide preparation. From July 2003 to September 2006 (3 years 3 months) Contract Project Manager @ Developed protocols for three international Phase III and two Phase III women's health studies and initiated one Phase III international study. Responsibilities included creation and maintenance of study timelines and budgets; management of clinical, data management, laboratory, and IVRS vendors; leading internal multidiscipline study team meetings routinely; planning for Investigator Meeting; and clinical supplies planning. From February 2003 to July 2003 (6 months) Contract Project Manager @ Managed two global anesthesia/pain clinical studies from close of enrollment through database closure. Responsibilities included management of clinical and data management CROs, development of table and listing format, review and oversight of clinical study report and study abstract; and maintenance of study budget. From October 2002 to February 2003 (5 months) Contract Project Manager @ Managed a large Phase III study and initiated a Phase IV clinical study for a marketed diabetes product. Responsibilities included protocol design and development; management of clinical, data management, laboratory, IVRS, and advertising vendors; preparation of a case to retain a vendor resulting in over a $1M cost avoidance for the company; designed and implemented a CRO improvement plan; co-monitoring of study sites; and review of tables, listings and final study report. From January 2002 to October 2002 (10 months) Contract Project Manager @ Managed a Phase IIII study for an investigational depression product. Responsibilities included management of clinical, data management, ECG and laboratory vendors; co-monitored and audited study sites; adhered to timelines and study budget; generated a close out plan and timelines for seven Phase III studies upon discontinuation of program and followed to completion, including ophthalmic follow up of all subjects; reviewed integrated safety report. From August 2000 to January 2002 (1 year 6 months) Clinical Research Associate @ Managed a Phase IIII study for an investigational HIV product. Responsibilities included management of clinical, data management, and ECG and laboratory vendors; co-monitored and audited study sites; coordinated regulatory submissions to 14 countries; participated in NDA activities including writing of integrated safety and efficacy reports. From April 1999 to August 2000 (1 year 5 months) Product Specialist and Training Coordinator @ Manufactured and tested marketed products in compliance with GMP/GLP regulations. Developed clinical protocol and informed consent form in support of two hepatitis antibody diagnostic assays. Coordinated IRB submissions. Coordinated manufacture of diagnostic kits at Abbott affiliates in Germany and Ireland. Successfully led team of seven in completing protocol activities. Designed and implemented technician training program for department of fifteen. From June 1996 to April 1999 (2 years 11 months) Quality Assurance Auditor @ Audited manufacturing and testing laboratory documentation for compliance with GMP and GLP. Performed internal audits of manufacturing and testing laboratories. Prepared written reports and assisted in preparation of corrective action plans. From May 1995 to June 1996 (1 year 2 months)

Bachelor of Science, Biology @ Indiana University Bloomington From 1991 to 1995