Danielle Mcmanus Email & Phone Number

Greater Boston Area

Management of TESARO’s electronic document management system as well as the company documents and records maintained in the system.Propose quality improvements to document control systems and procedures to maintain compliance and improve efficiencies.Implement efficiencies to processes or system which may include writing procedures, deviations and or.

Greater Boston Area

Cambridge, MA

• Acts as primary contact and support to assigned departments for LMS/Net Dimensions and training related issues. Fields questions and issues from functional staff.
• Created training matrices for all roles in the Commercial/QA/Compliance organization
• Facilitate many in-person trainings including bi-weekly New Hire Orientation
• Troubleshoots issues and suggests plans for corrective action as needed.
• Provides reports and support as needed for corporate quality… Show more
• Provides reports and support as needed for corporate quality audit/inspection activities

Cambridge, MA

document management system administration assist QA Documentation with operational activities including;data entry scanning maintaining files in QFR (quality file room) archiving and assisting with offsite archival processes and procedures compiling reports auditing executing small scale administrative projects updating spreadsheets

Greater Boston Area

• Assist with site qualification process IE: site survey and test transfer submissions
• Ensure study start up packages and requested supplies are sent in a timely manner
• data entry of incoming imaging data
• In compliance with Good Clinical Practices (GCP), regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocols
• Perform established image processing techniques (extraction of image data from media, converting… Show more
• Perform established image processing techniques (extraction of image data from media, converting imaging formats) across multiple modalities (specifically CT, MRI, Echocardiogram Ultrasound) using proprietary software.

Hudson, NH

Confirmed that classrooms were appropriately staffed and up to ratioSet up staff meetings and staff outingsMaintaining employee and student filesArrange teacher workshop classesArrange parent teacher conferencesMaintained career development of teachersLiaison with the Department or Health and Human Services for the Center Conducted web billing for children.

Filing, copying, faxing, setting appointments and meetings and other office dutiesMaintain regulated nonclinical study archiveMaintain regulated status of GLP study files and dataMaintain GLP study data chain of custodyConducted formatting on authored documents according to the submissions standards guide, while communicating with the author/editor.

Staff Supervisor, Curriculum Facilitator, as well as Lead Teacher of the Preschool program