• Conduct qualification, initiation, interim monitoring, and close-out visits in accordance with the Monitoring Plan • Ensure investigational sites remain compliant with the approved protocol, regulatory requirements, and Sponsor SOPs • Perform source data review and verification to ensure accuracy, completeness, and traceability of clinical data • Review and ensure timely reporting of adverse events and device deficiencies • Support preparation of FDA Annual Reports and regulatory submissions as applicable • Maintain and reconcile TMF/eTMF documentation to ensure inspection readiness • Provide site training on investigational plan requirements and study procedures • Collaborate with Regulatory Affairs and Data Management to resolve data and compliance issues • Escalate protocol deviations, compliance concerns, or site performance issues as appropriate • Support internal and external audit readiness activities

• Provides field support for clinical research related enrollment and procedures • Serve as a technology, protocol and clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site • Develop and maintain in depth knowledge of clinical trial sites • Understand and assess investigators’ interests and qualifications • Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code • Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel • Proactively and critically examine ways to enhance overall clinical trial performance • Facilitate communication between clinical trial sites and other Abiomed clinical staff (e.g., CRA, study team, Contracts Associate), as needed • Manage the following aspects of study progress, including, but not limited to: Start Up o Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution • Facilitate contract/budget escalations as part of the start-up process • Train facility staff regarding protocol requirements and technology • Develop site-specific strategies to promote appropriate patient enrollment • Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement • Provide ongoing feedback concerning all aspects of study progress, specifically enrollment and procedure related, for the purpose of developing and implementing strategies that will optimize patient safety and contribute to organizational and corporate goals/objectives • Provide support for all study-related aspects to research partners, including but not limited to the following questions: technical, protocol, standard of care, clinical trial reimbursement, etc. • Provides on call, bedside clinical trial case coverage for multiple clinical trials and clinical trial sites • Provides back up support in the following areas, trouble shooting, in-service training to physicians and healthcare professionals • Responsible for product reporting and troubleshooting with customers and field personnel within the clinical research portfolio • Collaborate with and provide feedback to Clinical Scientists and study teams in the development of clinical study deliverables, such as protocol design, source documentation, work instructions, patient recruitment materials and product training • Identify and communicate best practices relevant to clinical trial execution • Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities • Collaborate with Clinical Affairs, Medical Affairs, R&D, marketing, and commercial teams to support and advance key projects • Serve as a scientific interface with healthcare professionals • Act as resource in corporate product education as it relates to investigative technologies, as necessary • Develop collaborative cross-divisional team relationships • Provides engineering, education and clinical support in response to field-based inquiries on as needed basis • Transfers clinical trial knowledge and experience into meaningful input and feedback to cross functional partners in R&D, medical affairs, marketing, sales, and education • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

• Provides field support for clinical research related enrollment and procedures. • Serve as a technology, protocol and clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site. • Develop and maintain in depth knowledge of clinical trial sites. • Understand and assess investigators’ interests and qualifications. • Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code. • Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel. • Proactively and critically examine ways to enhance overall clinical trial performance. • Facilitate communication between clinical trial sites and other Abiomed clinical staff (e.g., CRA, study team, Contracts Associate), as needed. • Manage the following aspects of study progress, including, but not limited to: Start Up o Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution. o Facilitate contract/budget escalations as part of the start-up process. Train facility staff regarding protocol requirements and technology. o Develop site-specific strategies to promote appropriate patient enrollment. Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement. o Provide ongoing feedback concerning all aspects of study progress, specifically enrollment and procedure related, for the purpose of developing and implementing strategies that will optimize patient safety and contribute to organizational and corporate goals/objectives. • Provide support for all study-related aspects to research partners, including but not limited to the following questions: technical, protocol, standard of care, clinical trial reimbursement, etc. • Provides on call, bedside clinical trial case coverage for multiple clinical trials and clinical trial sites. • Provides back up support in the following areas, trouble shooting, in-service training to physicians and healthcare professionals. • Responsible for product reporting and troubleshooting with customers and field personnel within the clinical research portfolio. • Collaborate with and provide feedback to Clinical Scientists and study teams in the development of clinical study deliverables, such as protocol design, source documentation, work instructions, patient recruitment materials and product training. • Identify and communicate best practices relevant to clinical trial execution. • Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities. • Collaborate with Clinical Affairs, Medical Affairs, R&D, marketing, and commercial teams to support and advance key projects. • Serve as a scientific interface with healthcare professionals. • Act as resource in corporate product education as it relates to investigative technologies, as necessary. • Develop collaborative cross-divisional team relationships. • Provides engineering, education and clinical support in response to field-based inquiries on as needed basis. • Transfers clinical trial knowledge and experience into meaningful input and feedback to cross functional partners in R&D, medical affairs, marketing, sales, and education. • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

• Provides field support for clinical research related enrollment and procedures. • Serve as a technology, protocol and clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site. • Develop and maintain in depth knowledge of clinical trial sites. • Understand and assess investigators’ interests and qualifications. • Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code. • Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel. • Proactively and critically examine ways to enhance overall clinical trial performance. • Facilitate communication between clinical trial sites and other Abiomed clinical staff (e.g., CRA, study team, Contracts Associate), as needed. • Manage the following aspects of study progress, including, but not limited to: Start Up o Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution. • Facilitate contract/budget escalations as part of the start-up process. • Train facility staff regarding protocol requirements and technology. • Develop site-specific strategies to promote appropriate patient enrollment. • Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement. • Provide ongoing feedback concerning all aspects of study progress, specifically enrollment and procedure related, for the purpose of developing and implementing strategies that will optimize patient safety and contribute to organizational and corporate goals/objectives. • Provide support for all study-related aspects to research partners, including but not limited to the following questions: technical, protocol, standard of care, clinical trial reimbursement, etc. • Provides on call, bedside clinical trial case coverage for multiple clinical trials and clinical trial sites. • Provides back up support in the following areas, trouble shooting, in-service training to physicians and healthcare professionals. • Responsible for product reporting and troubleshooting with customers and field personnel within the clinical research portfolio. • Collaborate with and provide feedback to Clinical Scientists and study teams in the development of clinical study deliverables, such as protocol design, source documentation, work instructions, patient recruitment materials and product training. • Identify and communicate best practices relevant to clinical trial execution. • Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities. • Collaborate with Clinical Affairs, Medical Affairs, R&D, marketing, and commercial teams to support and advance key projects. • Serve as a scientific interface with healthcare professionals. • Act as resource in corporate product education as it relates to investigative technologies, as necessary. • Develop collaborative cross-divisional team relationships. • Provides engineering, education and clinical support in response to field-based inquiries on as needed basis. • Transfers clinical trial knowledge and experience into meaningful input and feedback to cross functional partners in R&D, medical affairs, marketing, sales, and education. • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.