Ashley Cramer Email & Phone Number

Philadelphia, Pennsylvania, US

• Oversee assigned team
• Monitor the productivity and quality of the Clinical Data Management team.
• Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns
• Define the Data Management Plan (DMP) through collaboration with clients, Project Management and Account Management
• Wide-ranging interactions with the Sponsor and SAS Programmers, lead the development, review, and finalization of data transfer requirements.
• Ensure the quality of study set-ups by participating in the review and approval process for all Data Management owned modules.

Wilmington, NC, US

• Lead all CDM activities relating to the delivery of subject data for clinical trials
• Work directly with clients to reach a complete understanding of customer needs, contractual timelines and deliverables
• Work across departments to exceed customer expectations
• Provide ongoing, quality communications and deliverables for projects
• Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.
• Acts as a liaison to the PM and/or client as required and communicates with management regarding all data management (DM) activities within their studies.

Philadelphia, Pennsylvania, US

-Oversee assigned team-Monitor the productivity and quality of the Clinical Data Management team.-Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns-Define the Data Management Plan (DMP) through collaboration with clients, Project Management and Account Management-Wide-ranging interactions with the Sponsor.

Philadelphia, Pennsylvania, US

• Company formerly known as ERT
• Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including, but not limited to Data collection, Data cleaning, Data delivery, Data reconciliation, Database lock and.
• Define the Data Management Plan (DMP), in collaboration with study Sponsors to define study requirements and Query guidelines
• Work with internal teams on study setup requirements such as demographic collection and visit schedule requirements.
• Maintain good communications with related teams
• Lead the development, review, and finalization of data transfer requirements

Philadelphia, Pennsylvania, US

• Company formerly know as ERT
• Exporting and cleaning data prior to providing routine data transmissions to the Sponsor and ensuring data is provided to Sponsors according to the Task List.
• Interpreting Edit Check Outputs.
• Making Data edits, creating and/or resolving queries, performing data reconciliation, and understanding workflow to ensure all appropriate data is provided to the Sponsor.
• Monitor the Task List daily to ensure all data deliverables are met while proactively notifying Data Manager if issues occur.
• Assist with process improvement projects, such as SOPs and SWI creations/revisions.

Canonsburg, Pennsylvania, US

• Compile release and stability data utilizing the Laboratory Information Management System (LIMS)
• Retrieve data from Trackwise and/or communicate with the pertinent site groups for all investigations, CAPA, and trending records pertaining to Raw materials, excipients, packaging components, finished product and.
• Retrieve data from SAP and/or communicate with the pertinent site groups to determine the batches manufactured, packaged or released during the annual review period
• Analyze the information collected and identify issues, trends, determine APR level classification, and propose recommendations to management that affect product, manufacturing, packaging, and stability. Compile summary.
• Attend/facilitate periodic APR committee meetings to report findings of potential product issues.
• Obtain information regarding Technical/Quality agreements as related to the APR from Quality Compliance

Canonsburg, Pennsylvania, US

• Review and approve Raw Material, Finished Product, Blends, Intermediate Products, Special Tests, and Complaints for accuracy, completeness, and compliance with current regulatory specifications, in-house limits, and.
• Work with analysts on investigation work
• Excel spreadsheets and tracking of products

Canonsburg, Pennsylvania, US

• Test raw materials, blends, intermediates and finished product to ensure a quality product that is safe to release to the public
• Review and process data, while interpreting test results and ensure that they meet specifications
• follow cGMP documentation practices
• team work
• troubleshooting instrumentation and investigating aberrant test results
• perform analytical investigations

Pittsburgh, PA, US

• Experiments involving cell culture and molecular techniques
• Characterization of human DNA sequence variation
• DNA manipulation and sequencing
• Real-time PCR (taqman)
• Organizing, analyzing, and reviewing the resulting data and troubleshooting experiments
• Tracking/record keeping of samples from several independent studies