Experienced clinical study professional with extensive background tracking clinical trials throughout the entire drug compliance lifecycle. Accomplished in drug supply logistics, data integration and clinical applications. Familiar with Phase I, II, III and IV trials in GI, Respiratory, Oncology, Central Nervous System, Cardiology, Pain/Anesthesia and Infectious Disease. Special talents include experience in project management, leadership, customer service, mentoring, and team building. Excellent business management, analytical and organizational skills. Particular strengths include detail orientation with a reputation for accuracy and meeting timelines.

EXPERIENCE

Confidential, Philadelphia, PA Aug 2008 - Present
Project Manager/Coordinator - Drug Supplies and Logistics and Integrations

• Responsible for creation and management of supplies and logistics from specification to final delivery
• Manage global drug shipping, labeling and storage activities in accordance with ICH guidelines
• Coordinate and control order cycle and associated information systems
• Monitor the quality, quantity, cost and efficiency of the movement of supplies
• Manage return and destruction of unused materials and conduct reconciliation of supplies
• Generate queries to reconcile drug inventory
• Liaise with study team, site personnel and global support representatives to ensure timely re-supply
• Manage cold chain handling, storage and shipping requirements for vaccines and temperature sensitive supplies
• Design and manage Interactive Voice Response System (IVRS) specification for clinical and drug supply application through protocol review
• Manage, research and resolve implementation processes and report all serious deviations to management
• Manage end user business practices, concepts and terminology to support the clinical application
• Manage quality assurance on application functionality through data reconciliation
• Author and manage data integration specifications, guidelines and processes for external data transfer
• Create project plans, system documentation, education materials, reference documents and process improvement workflows
• Conduct training of end users in operating procedures for application
• Regularly meet with users, vendors and IT staff to develop/modify system specifications
• Provide technical support to sponsor entities as needed
• Coordinate Mentoring Program
• Adhere to Project Management standards

Confidential, Wilmington, DE Oct. 2001 - Oct. 2007
Project Manager - Clinical Applications

• Spearheaded the development and maintenance of processes and procedures to capture and maintain Oncology study-related information within an Oracle-based clinical trials database repository (IMPACT).
• Coordinated the development and monitoring of critical set-up criteria with cross-functional study teams
• Managed business processes surrounding system usage, critical reporting needs and ad-hoc reporting
• Established and maintained key performance indicators and analytical trending metrics reports
• Provided clinical and regulatory expertise and guidance to study teams surrounding:
• Clinical compliance
• Drug Shipment Regulatory Interface
• Investigator Safety Letter Distribution
• Designed test scripts and user acceptance testing requirements for system upgrade
• Developed instructional training materials, job aids and reference documents to support system usage
• Delivered regularly scheduled training to Clinical Study Management, Study Delivery, Regional Monitors and other businesses
• Developed and deployed communication strategies to ensure smooth and efficient knowledge transfer
• Maintain and use systems: IMPACT (International Management Package for the Administration of Clinical Trials),
• DSRI (Drug Shipment Regulatory Interface), DIRM (Document Information Retrieval Management), Samson (Investigator Safety Letter Shipment), GEL (Global Electronic Library)
• Coordinate internal and external meetings including study teams, monitors, regulatory personnel, and physicians
• Work with study teams to share knowledge, experiences and best practices

Confidential, Wilmington, DE Feb. 2001 - Oct. 2001
Study Delivery Associate with AstraZeneca Clinical Study Management

• Lead, initiate, track and close Study Master File ensuring GCP/ICH compliance standards
• Accountable for contributions to the clinical study start-up execution, close out and reporting of clinical studies
• Collect, review, and track regulatory and other relevant documents critical for the Study Master File
• Communicate with CRO's, and Investigators during start up, maintenance and close out phases to support delivery of study
• Assist with coordination and tracking of study related supplies, equipment and documents
• Manage and utilize e-clinical systems: electronic clinical trial management tracking, eCRF database, Study Master File Database, study webs, and drug shipment.
• Perform data management activities including data review, issue and resolve queries, work with CRA's and sites to resolve data issues, track data review and report to study team on progress and trends

Confidential, Wilmington, DE Sept. 1989 - Mar. 1993
Special Projects Administrator - Corporate Research and Development

• Developed corporate R & D business projects
• Administered and maintained academic R & D research repository
• Developed and managed ICI Summer Fellowship Program
• Contributed to budget and capacity planning
• Researched and analyzed market trends and shifts
• Packaged and reported research trends to management
• Presented grant proposal for project funding to National Science Foundation

Education

Bachelor of Science in Education
Quality Assurance/ Regulatory Affairs Masters Program - 2 Semesters Completed
Organizational Development and Leadership Program - 1 Semester Completed

Computer Related Skills
Proficient in Microsoft Applications including Word, Excel, PowerPoint, Outlook and Visio
Proficient in following database systems: IMPACT (International Management Package for the Administration of Clinical Trials), DIRM (Document Information Retrieval Management), GEL (Global Electronic Library), PKT (Product Knowledge Transfer), MedDRA, WHODrug, Interactive Voice Response System (IVRS), Single Interface System