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 teams of eCOA timelines and ensured the study milestones were met.- Worked with teams to identify, document and improve pain points in the eCOA process and procedures

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 of investigators and site staff on study protocol and additional trial related documents- Communicated with global study manager about progress of testing conducted in the US- Supported Investigator at testing sites to answer questions concerning data capture, subject samples and trial related consumables

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.•Supports global standardization, alignment with other business areas, global divisional quality standards and compliance to global regulatory requirements together with the Global Account Managers.

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 pipettes for re-verificationSetup and maintenance of test systems, general lab maintenance, solvent preparation and working with C14 material

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 for North American and global organizations Performed initial feasibility studies using PCA/HK parameters provided by German colleagues for transferring the PCA/HK method currently run on the H917 to the cobas c501 clinical analyzer on the Indianapolis campus

- 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 troubleshooting of new drugs of abuse immunoassays by performing the following:Immobilizing of antibodies and conjugates to latex microparticlesPlacement of new immunoassays across various Roche platformsScale up of new immunoassays from milliliters to litersValidation experiments and methods of new immunoassays to meet or exceed FDA requirements- Compiled experimental data as per Roche Standard Operating Procedures to ensure compliance- Wrote and executed equipment validation documents to ensure regulatory compliance- Wrote internal reports for management in Indianapolis and Germany

- 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, search inventory, confirmation of labor, review goods issued and goods receipts from labor production- Trained by SP Industries in Freeze Dryer theories and was responsible for various clinical chemistries that required lyophilization