Elizabeth Acker Email & Phone Number

Work From Home

Franklin, In

Home Based

Our clinical data services division provides advanced pharmaceutical data services distinguished by experienced process design and Six Sigma quality. Our complete portfolio of services enables us to bring together the best people, processes, and technology to meet your global program of studies across all phases of research. Because i3 Statprobe focuses exclusively on the pharmaceutical and biotechnology industries, we can provide you more comprehensive and tightly integrated data service solutions.Specialties: Oncology

Lead CDMC for data validation on multiple Oncology and Critical Care trials.Facilitating and/or participating in the Study Development Process. Development and approval of the Data Validation/Data Review Plans and documentation of changes as well as for the development of study documents including CRF instructions and paperflow and ensures data management documents are inspection ready. Accountable for electronic CRF design, development, adherence to global data standards, testing and for eCRF review and approval.Coordinating identification of data requirements and integrated dataflow with the study team.Provide input into protocol design and monitoring profile.Accountable for user acceptance testing (UAT) of data entry/edit system as well as providing input on all study related reports generated by IT.Presenting/preparing data management materials as required in affiliate training and/or start-up meetings.Consulting in draft study report with Scientific Communication Associate/Therapeutic Area Associate/early phase coordinator/Statistician when applicable.Providing data management expertise to the teams for non-trial related activities (CIB, safety update, regulatory requests, etc.).Oversight of Clinical Data Review (CDR) for trial work using Clintrial, I-Review and InForm reporting in partnership with third party organization(s).Participation in multiple Six Sigma methodology project improvements including eCRF design, training, reports and validation projects.

Lead CDMA for data validation on multiple Critical Care, Neuroscience and Oncology trials.Resolving CRF indexing and AS400 logging issues, re-indexing as needed, reviewing on-line edits, reviewing CRF images vs. AS400, performing all checks (manual, edits, logic using quick reporter and IQ query) as specified in the data validation plan, generating queries and participating in query resolution, entering corrections into the AS400, generating lab fixes, communicating lab data issues with Clinical Diagnostic Services, and contacting affiliate personnel regarding outstanding issues and trends. Also responsible for compiling and identifying GCP non-compliance issues and communicating these with the data validation coordinator.Began pilot study using Phaseforward InForm software for electronic data collection.Providing training on the CT Scan imaging system including creation of training documents and class organization.