Global Clinical Project Manager @ • Manage the execution of the assigned clinical studies per contract, from initiation through to closeout, ensuring all project deliverables are completed to the Sponsor’s satisfaction From January 2011 to Present (5 years) Clinical Team Lead @ • Manages the planning and delivery of the clinical component of global projects in accordance with the scope of work, contracted timelines and study budget From November 1999 to December 2010 (11 years 2 months) Associate Clinical Scientist @ • Manages study start-up and clinical monitoring activities for global and regional multi-operational projects. From October 2006 to March 2007 (6 months) Sr. Clinical Research Associate @ • Responsible for monitoring clinical trials: assure adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures From October 2002 to September 2006 (4 years) Clinical Research Associate @ • Responsible for monitoring clinical trials: assure adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures From November 1999 to October 2002 (3 years) Drug Safety Associate @ • Review all Serious Adverse Events and co-ordinate reporting to domestic and foreign regulatory agencies • Write patient narratives, design and manage adverse event databases, and write safety updates and reports • Write and edit IND applications, annual reports, and final reports • Monitor Phase I through IIIb clinical trials in U.S. and Europe From December 1997 to May 1999 (1 year 6 months) Clinical Research Coordinator @ • Coordinate CNS I through III clinical trials with focus on Central Nervous System indications •Manage serious adverse event database for U.S. and European based clinical trials. From September 1995 to December 1997 (2 years 4 months) Clinical Research Coordinator @ • Co-ordinate pharmaceutical clinical drug trials, including indications of cardiac transplant, osteoporosis, and endocrinology related trials. • Facilitate co-ordination of 7 inter-institutional clinical trials, including cancer and diabetes trials. • Recruit subjects, collect and analyze subject data and monitor subject response. • Scan clinical and research subjects using Bone Densitometry machine and analyze results. • Interface with sponsoring pharmaceutical companies. • Collection of biological samples • Write protocols, consent forms, and edit scientific papers and grant proposals. From March 1994 to July 1995 (1 year 5 months) Technology Research Coordinator @ • Edit reports and legal documents such as license agreements and trademark applications. • Perform patent, trademark, company and other searches From February 1992 to February 1994 (2 years 1 month)

Harvard University From 1987 to 1992 Tracey Owens is skilled in: Clinical Trials, CTMS, Clinical Monitoring, CRO, GCP, ICH-GCP, EDC, Clinical Development, Clinical Research, Therapeutic Areas, Oncology, Patient Recruitment, Clinical Data Management, Pharmaceutical Industry, Regulatory Submissions, Clinical Operations