Ashley Case Email & Phone Number

Frederick, MD, US

• Directs all deliverables for the Data Management group for a medium to large complex project which includes overseeing the day to day work of 14 Clinical Data Managers and 2 system development teams. Independently.
• Providers leadership to the DM team through mentoring and guidance including creation and maintenance of project Work Processes and Guidance Documents.
• Communicates independently with external lead investigators, approves DSC external communication related to data management, as well as communicates internally with project leadership in other functional groups.
• Provides oversight of DM activities ensuring timeliness of quality deliverables for clinical research trials in study start-up through study close out.
• Reviews study budgets and and DM activities ensuring adherence to budget or escalation when there is potential budget overburn.
• Implemented processes to help junior DM staff be more aware of scope of work and budget allocations.

• Participate in study team calls and meetings to determine the requirements for the content and functionality of the electronic Case Report Forms (eCRFs)
• Design, develop, test and maintain eCRFs
• Train CTP staff on how to use the electronic data capture (EDC) system during in person meetings and webcasts
• Respond to questions about the EDC system that are submitted via phone or e-mail
• Develop Data Management documents (e.g., user’s guides and CRF instruction manuals, blank forms books) for the EDC system
• Perform regular data integrity and quality tasks

Reviews and processes clinical trial data to ensure the accuracy and consistency of clinical databases. Commonly performs the following data related activities: CRF tracking, reviewing, validation, updating, SAE reconciliation, lab data reconciliation and safety coding. Provides accurate, timely, and consistent clinical data to both sponsors and other.

Provides support for project teams. Reviews and resolves discrepancies, maintains all necessary documentation to support the accuracy of the clinical database and generates and reviews data listings, tables and graphs. Participates in client team meetings and prepares meeting agendas and minutes. Develops and maintains Completion Guidelines, Data handling.

B.S., Psychology

Psychology