Dan Hand Email & Phone Number

Indianapolis, Indiana, United States

Indianapolis, Indiana Area

Indianapolis, Indiana Area

- Supported study teams during the design and execution of electronic Clinical Outcomes Assessments (eCOA) in various therapeutic areas- Provided guidance to study teams in regards to copyright, translation validation, device shipment and training- Communicated with eCOA vendor to ensure the proper documentation in place for software development - Notified.

Indianapolis, Indiana Area

- Designed, planned, coordinated and conducted the following activities involved in performing site assessment visits, preparing study documents, submitting sites for contracting and purchasing, initiating sites, reviewing data, troubleshooting discrepant results, monitoring sites for clinical research trials and closing out of clinical studies- Training.

Indianapolis, Indiana Area

• Oversees and supports the set up and execution of clinical trials from the data management and facilitating systems perspective. Roles & Responsibilities:
• Consultant during the DIA system (WinCAEv ) definitions and analyzing phase with the perspective of the study protocol and final data analysis.
• Supports Clinical Operations Study Managers in preparation of the experimental part of the study protocols, definition of the studies, evaluation and analyzing of complex studies.
• Support and administration in all studies that uses DIA systems (WinCAEv ) for executing professional studies in external fields.
• Supports the development of one or more DIA systems (WinCAEv ) according the changing needs of RPD.
• Assist the Global Account Manager in one or more DIA systems representing Clinical Operations on the development teams to ensure the future development is in alignment with the RPD strategy.

Worked in Regulatory Affairs assisting in analytical studies to provide quantitative trace level analyses of analytes in environmental matricesPerform sample preparation, solid phase extraction and combustions of various matricesFocal Point for HPLC system efficiency checks, Soil Sieving, defrosting freezer/refrigerator and cleaning and redistribution of.

Worked in Diabetes Care Quality Care performing code assignment and verification on new glucose strip lots for the Aviva, Freedom and Performa product linesRan PCA/HK samples on the Hitachi 917 for the Comfort Curve product line to evaluate code verificationWrote protocols for preparation and shipment of samples for new Quality Control harmonization plan.

- Worked on an off site assignment for 18 months in a collaborative effort with a distinguished diagnostic company which included the following: Placement of new and existing drugs of abuse assays on a non-Roche clinical analyzerTraining of other scientists in the operation of the analyzer and use of Roche assays- Responsible for development and.

- Responsible for production of simple to complex liquid bulk clinical chemistry and DAT reagents in a ISO 9001, GLP, GMP environment- Aided in calibration and verification of instrumentation- Member of the Production Quality Control Council that brought possible production issues to the attention of management- Experience on SAP to issue goods to orders.