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 change controls.Serves as a sub business administrator for EDMS, assists with configuration settings, generation of new document… Show more 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 change controls.Serves as a sub business administrator for EDMS, assists with configuration settings, generation of new document types, custom fields, account creation and training assignment management.Provides guidance to customers regarding the document lifecycle process and systems.Generates and tracks Key Performance IndicatorsProvides support during regulatory inspections.Assist in any documentation related projects as needed.Support electronic system validation and lifecycle maintenance for the Learning Management System (LMS)Support the Training Program SME and Documentation Management SME in all Regulatory Inspections and Partner Audits as the (SME).Support the review of GxP Documentation for formatting, compliance with established templates, and accuracy to cross linked documentation.Share the responsibilities and support the activities and of the Global Quality Systems and GxP Compliance group as required. Show less

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 • 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 audit/inspection activities• Creates and manages course items (sets prerequisites, initial & re-training periods, substitutes);• Creates and manage online exam objects and content;• Creates and manage subject-area curricula• Coordinates training assignment for employees in assigned areas• Runs reports in Plateau/Net Dimensions upon request• Assists the QA Training and Documentation Management with on-going review of training assignments and refinement of role-based curricula• Work as Documentation and/or Training representative to ensure that all documents are initiated into workflow and put into pending release in the LMS/Net Dimensions in a timely manner• Ensure accuracy of submissions (content, template)• Review and approve responsibilities and curriculum for all new and revised documents• Review and approve information sheets to initiate EDCS workflow for all new and revised documents• Work with document authors to develop training curriculum in the LMS/Net Dimensions• Review training plans and work with document authors to ensure that information is adequate and complete. • Provide final approval for training plans to allow documents to enter the LMS• Facilitate the execution of all training plans in the LMS/ Net Dimensions• Instrumental in helping to switch and implement a new, Global LMS system. • Participated in Pre/post go-live activities of Takeda’s switch from Plateau to Net Dimensions.• Took the lead on Soft/Go live implementation activities and delegated setup activities. Show less

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 • 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 imaging formats) across multiple modalities (specifically CT, MRI, Echocardiogram Ultrasound) using proprietary software as well as other third party software • Ability to prioritize and manage time sensitive tasks for multiple projects • Maintain project specific central files • Ongoing site correspondence over the duration of the clinical trial Show less

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 on state assistance to the Department of Child and Family services

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 Controlled document life cycle managementGeneral quality compliance

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