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.• Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times.• Assist in the preparation of monthly reporting by providing metrics as required• Develop, review and revise Standard Operating Procedures, Standard Work Instructions, Job Descriptions and Departmental Training as needed. Create and or/review and approve SOPs and SWIs to ensure best practices are defined and followed during the lifecycle of a study.• Assist Business Development and Quality Assurance with internal and external clientOTHER DUTIES AND RESPONSIBILITIES:• Communicate project status clearly with Sponsors and Project Management• Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation• Lead in resolving CAPA issues related to study-specific data management activities• Work with the Director to develop training programs• Administer training as needed• SME and POC for a specific client

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. • Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines. • Develops and delivers study specific training for DM project staff. • Produces project-specific status reports for management, PM and/or clients on a regular basis. Monitors study metrics.• Participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required. Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Managers and management and assists with the Contract Modification process. • Mentor junior level staff on all associated tasks within a study. • Assists with the administrative and financial management of allocated projects. Performs all assigned data management activities independently and efficiently, with attention to quality.

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.-Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times.-Assist in the preparation of monthly reporting by providing metrics as required-Develop, review and revise Standard Operating Procedures, Standard Work Instructions, Job Descriptions and Departmental Training as needed. Create and or/review and approve SOPs and SWIs to ensure best practices are defined and followed during the lifecycle of a study.-Assist Business Development and Quality Assurance with internal and external clientOTHER DUTIES AND RESPONSIBILITIES:-Communicate project status clearly with Sponsors and Project Management-Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation-Lead in resolving CAPA issues related to study-specific data management activities-Work with the Director to develop training programs-Administer training as needed

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 Data Management activity timelines•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•Serve as primary point of contact for query escalation•Routinely review and resolve escalated queries•Provide consolidated escalated query listings to Sponsor teams•Prepare study database for archiving for Sponsors and sites•Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times.•Identify out of scope requests and elevate these requests to the Project Manager so that they can be properly billed through the Change Order process.•Maintain Data Management Files•Conduct routine status meetings with Sponsor/CRO and internal teamsOTHER DUTIES AND RESPONSIBILITIES:•Communicate project status clearly with Sponsors and Project Management•Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation•Lead in CAPA issues related to study-specific data management activities•Process at least one routine data run per assigned study per quarter and perform all sample, complete and final data sends•Assist in the preparation of monthly reporting by providing metrics as required•Efficient in: StudyWorks, EPX, SQL, Excel •Serve as a mentor

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.• Maintain study files including all documentation of database edits.• SQL, SAS, GENSAS• Manage Paper QoLs email folder and entry of Qols• Assist to Data Managers as backups for deliveries sent to clients• Completely manage all data management aspects of clinical trials• Generating and updating DMQP’s

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 stability acquired within the annual review period• 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 reports with all appropriate information and maintain electronic files• 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•Obtain information for process, cleaning, and test method validation utilizing Manufacturing Tech Support, Validations, Quality Compliance and/or the appropriate Management System(s). Knowledgeable in FDA and cGMP Regulations.

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 laboratory policies. •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• ability to work in a fast paced/stressful environment

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• Placing orders for laboratory supplies and equipment needs• Laboratory training of students and new personnel•Stem Cell/Cell Culture Hands on training January 2011•Manuscript published in the Journal of Dental Research: "Insights from studies with oral cleft genes suggest risk of oral cancer" •Abstract presented: “Gene-gene interaction of AXIN2/IRF6 may contribute to oral clefts”•Poster Presentation for SCIENCE 2010 titled: Studies of the WNT Pathway Genes and Head and Neck Cancer