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Plan, coordinate, and arrange study communications and critical meetings on and off site with both internal and external attendees. Responsible for drafting Meeting Agendas and detailed Meeting Minutes for review and approval by Clinical Project Manager/Clinical Program Manager. Set up, update, maintain and close Trial Master Files. Assures currency and accuracy of required clinical trials documen
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Conversion of user needs and design inputs into software specification. Design, development and test algorithms per medical device software development life cycle (IEC 62304) Participate in software risk analysis and mitigation. Collaborate with cross functional team members, including clinicians, data scientists in further refinement and development of advanced algorithms. Prepare and maintain pr
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Process all payrolls using ADP Workforce Now including time and attendance system. Support and work with HR to ensure employees are paid accurately and on time. Resolve employee pay issues. Process garnishment of wages. Review payroll tax filings. Process payroll related tax issues. Prepare manual checks. Process year end W 2's and related year end filings. Prepare journal entries to record labor
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Manage and execute a highly complex study for a Class III device Effectively manage a study that enrolls high risk patients in a fast paced environment Conduct clinical research programs in accordance with approved project plans Project development, execution & performance tracking (risk management, administration and issue resolution) Comprehensive study management for clinical study, including b
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Review all assigned clinical and product complaints for medical device events Interface with field reps. and clinical staff to acknowledge, document and obtain detailed information regarding adverse events and incidents received by the company Apply knowledge of medical device regulatory requirements to support the reporting decision process and identify reportable events as they are received Com
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Responsible for comprehensive study management for clinical study, for example protocol and database development, site management project planning, Chair core team meetings for assigned studies ensuring goals and deliverables are clearly defined, and issues, decisions, risks and actions are appropriately tracked Responsible for project development & performance tracking and risk management Maintai
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Receives global cross functional assignments in the form of objectives and determines how to meet schedules and goals. Responsible for the development of all Quality Control Plans/related documents and oversees/performs implementation of quality control activities for assigned projects according to committed timelines. Conducts Quality Control activities which include, but are not limited to the f
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Assist Associate Director, Clinical Operations with mapping out a comprehensive training program for new hires including the preparation of electronic and paper based on boarding materials. Assist with assessing training needs for new and existing employees as well as external vendors (i.e., core labs, CRO/ARO etc.) and identifying training activities/systems to address competency gaps, as identi
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Develop and drive innovative programs to expand awareness and adoption of Impella as the preferred treatment option amongst the treating physician, referring physician and patient communities. Develop concerted marketing programs/sales campaigns based on segmentation to drive marketing and commercialization strategy. Effectively launch/distribute/disseminate Abiomed's innovative products, key me
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Leads/Support the development, maintenance, optimization and support of one or more clinical applications. Collaborates with identified stakeholders to identify user requirements and subsequently implement solutions to promote efficiency, compliance and best practice. Author/Support the creation and review of departmental SOPs, Work Instructions, and training materials. Ensures that the design an
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Create the strategic vision for, manage and execute a highly complex study for a Class III device Effectively manage a study that enrolls high risk patients in a fast paced environment Conduct clinical research programs in accordance with approved project plan Project development, execution & performance tracking (risk management, administration, financial management, budgeting and issue resolutio
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Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission "Patients First." With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,000 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional t
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Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives . With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborati
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Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives . With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborati
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Work as part of a team, as well as individually, in Chemical and Biological/Blood laboratories Set up and non regulated maintenance of equipment, such as for example FTIR microscope, DSC, HPLC, TEG, as well as new instruments Conduct material chemistry tests and experiments Record, analyze, and report data Present results in team and group meetings Generate test procedures based on critical review
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