Role Description We are searching for the best talent for Clinical Site Manager. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. This is a remote role available in all states/cities within The United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Responsibilities - Serve as Subject Matter Expert (SME) for monitoring and site management activities conducted on assigned clinical studies. - Review of study level trends, escalations, and action items to ensure overall site management efficiency. - Review monitoring visit reports to ensure compliance with Abiomed procedures and study plans. - Serve a critical role as liaison and facilitate meetings between project stakeholders to ensure study tasks and deliverables are on track. - Provide direction and guidance to execute project deliverables in collaboration with project/program managers. - Provide strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site). - Act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form. - Determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. - Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements. - Train and proctor new employees on trial and study related activities. - Resolve complex trial/study data and regulatory documentation discrepancies escalated by junior level employees. - Develop Clinical Research Associates to increase business acumen and functional skills; act as a mentor to new or junior level employees. - Support the development of site training, recruitment, and required study related content and materials. - Support CRAs through study start up process, ensuring collection of appropriate documentation and timely review of documentation including but not limited to budgets, clinical research agreements and informed consents. - Participate in development and validation of case report forms, when applicable. - Review and complete checklist on informed consent forms (ICF), as needed. - Develop a familiarity with the protocols to ensure adherence to study timelines, inclusion and exclusion criteria, and enrollment goals. - Support of review of Standard Operating Procedures (SOPs); Work Instructions and engagement in process improvement initiatives. - Support conduct of Site Initiation Visits; train site personnel on sponsor and regulatory requirements for study conduct. - Participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation. - Support conduct of Site Monitoring (Site Management or Interim Monitoring Visits) Visits and follow-up to identify significant problems and issues. - Ensure that all clinical aspects of studies are being carried out in accordance with study. - Support conduct of Site Close-out Visits and follow-up to ensure all site related activities and documents are complete and filed in the eTMF. - Develop tools, trackers, and project specific training materials. - Assist in the auditing of clinical trials. Qualifications - Bachelor's Degree or equivalent in science-related field with at least 5 years previous field monitoring experience. - 2-3 years in a Lead CRA or project management type of role. - Experience with electronic data capture and Clinical Trial Management Systems required (Veeva Vault CTMS/eTMF and Medidata/Rave EDC preferred). - Prior experience supporting trials for Class II/III medical devices. - Familiarity with quality assurance/control processes and regulatory compliance. - Proven expertise in MS Office Suite, including Word, Excel, and Adobe. - Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives. - Excellent problem-solving, organizational, analytical, and critical thinking skills. - Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA/Project Management certification) preferred. - Master's Degree or equivalent with Experience working in a regulated industry preferred. - Ability to travel up to 50% (throughout the US), as required. Benefits - Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Consolidated retirement plan (pension) and savings plan (401k). - Annual performance bonus based on individual and corporation’s performance. - Vacation – up to 120 hours per calendar year. - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year. - Holiday pay, including Floating Holidays – up to 13 days per calendar year. - Work, Personal and Family Time - up to 40 hours per calendar year.

Role Description We are searching for the best talent for Clinical Site Manager. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. This is a remote role available in all states/cities within The United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Responsibilities - Serve as Subject Matter Expert (SME) for monitoring and site management activities conducted on assigned clinical studies. - Review of study level trends, escalations, and action items to ensure overall site management efficiency. - Review monitoring visit reports to ensure compliance with Abiomed procedures and study plans. - Serve a critical role as liaison and facilitate meetings between project stakeholders to ensure study tasks and deliverables are on track. - Provide direction and guidance to execute project deliverables in collaboration with project/program managers. - Provide strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site). - Act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form. - Determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. - Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements. - Train and proctor new employees on trial and study related activities. - Resolve complex trial/study data and regulatory documentation discrepancies escalated by junior level employees. - Develop Clinical Research Associates to increase business acumen and functional skills; act as a mentor to new or junior level employees. - Support the development of site training, recruitment, and required study related content and materials. - Support CRAs through study start up process, ensuring collection of appropriate documentation and timely review of documentation including but not limited to budgets, clinical research agreements and informed consents. - Participate in development and validation of case report forms, when applicable. - Review and complete checklist on informed consent forms (ICF), as needed. - Develop a familiarity with the protocols to ensure adherence to study timelines, inclusion and exclusion criteria, and enrollment goals. - Support of review of Standard Operating Procedures (SOPs); Work Instructions and engagement in process improvement initiatives. - Support conduct of Site Initiation Visits; train site personnel on sponsor and regulatory requirements for study conduct. - Participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation. - Support conduct of Site Monitoring (Site Management or Interim Monitoring Visits) Visits and follow-up to identify significant problems and issues. - Support conduct of Site Close-out Visits and follow-up to ensure all site related activities and documents are complete and filed in the eTMF. - Develop tools, trackers, and project specific training materials. - Assist in the auditing of clinical trials. Qualifications - Bachelor's Degree or equivalent in science-related field with at least 5 years previous field monitoring experience. - 2-3 years in a Lead CRA or project management type of role. - Experience with electronic data capture and Clinical Trial Management Systems required (Veeva Vault CTMS/eTMF and Medidata/Rave EDC preferred). - Prior experience supporting trials for Class II/III medical devices. - Familiarity with quality assurance/control processes and regulatory compliance. - Proven expertise in MS Office Suite, including Word, Excel, and Adobe. - Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives. - Excellent problem-solving, organizational, analytical, and critical thinking skills. - Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA/Project Management certification) preferred. - Master's Degree or equivalent with Experience working in a regulated industry preferred. - Ability to travel up to 50% (throughout the US), as required. Requirements - Analytical Reasoning - Clinical Research and Regulations - Clinical Trial Designs - Clinical Trial Management Systems (CTMS) - Clinical Trials - Communication - Data Savvy - Laboratory Operations - Organizing - Problem Solving - Productivity Planning - Professional Ethics - Project Integration Management - Quality Assurance (QA) - Regulatory Compliance - Research and Development - Research Ethics - Standard Operating Procedure (SOP) Benefits - Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Consolidated retirement plan (pension) and savings plan (401k). - Annual performance bonus based on individual and corporation’s performance. - Vacation – up to 120 hours per calendar year. - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year. - Holiday pay, including Floating Holidays – up to 13 days per calendar year. - Work, Personal and Family Time - up to 40 hours per calendar year.

• Provides operational support to clinical pharmacists for the implementation, maintenance, submission, and ongoing management of clinical policies, drug lists, and benefit requirements • Collaborates with healthcare professionals, pharmacists, and business stakeholders to operationalize clinical policy strategies • Performs quality analysis and reporting to ensure effective operational execution • Creates process and training documentation as appropriate • Interprets Medicare and state-specific Medicaid regulations, benefit requirements, and operational guidance to support accurate implementation and maintenance of state-specific clinical policies and utilization management strategies • Partners with clinical, operational, and business stakeholders to ensure clinical policy intent is accurately reflected in formulary structures, utilization management criteria, and system configuration • Participates in cross-functional initiatives to streamline policy implementation, workflow management, and operational review processes across clinical and operational teams

Role Description - Provide subject matter expertise and contribute to the planning and delivery of a clinical development program to scope, quality, budget, time and managing risk as assigned by therapeutic and compound leadership. - Partner with therapeutic and functional leadership to define and operationalize program strategy. - Advise functional leadership on resourcing requirement for the applied operational strategy. - Responsible for providing clinical operations expertise into the clinical development plans for review by governance committees. - Drive the development and alignment of clinical documents (protocols, clinical study reports, investigator brochures, etc.), providing clinical operations expertise. - Provide clinical operations expertise into the country selection and feasibility to support project start-up and delivery. - Oversee study team deliverables, including enrollment, milestones, and inspection readiness. - Develop and oversee program timelines, budgets, forecasts, and key deliverables to ensure programs are executed on time, within budget, and with quality. - Contribute to study scope and provide approvals within delegated authority; contribute to vendor selection, contracting, and ongoing oversight to ensure quality, compliance, and performance. - Identify risks and issues related to program deliverables; develop and implement mitigation and action plans. - Act as the point of escalation for clinical study teams for risk and issues related to clinical studies, sites, and vendors. - Drive operational excellence across clinical programs through cross-functional collaboration with Clinical Development, Data Management, Biostatistics, Regulatory, and other stakeholders. - Responsible for leadership and program management of non-drug project work as assigned, e.g. cross functional improvement/change initiatives. - Contribute to functional and cross-functional initiatives as Subject Matter Experts. - Mentor, coach and support people development as appropriate. - Actively participate in networking both within and outside the therapeutic area, sharing best practices and lessons learned. - Be an early adopter for new ways of working and act as an ambassador for change, driving the implementation and utilization of initiative outputs. Qualifications - Extensive experience in clinical research within the pharmaceutical or biotechnology industry (typically 10+ years), with deep expertise in clinical operations. - Proficient understanding of global clinical trial regulations, ICH/GCP guidelines, and regulatory compliance requirements. - Capability to interact with functional leaders and major vendors, and in some cases senior leadership, on matters concerning program strategy and execution. - Proficient financial acumen in managing clinical trial budgets, forecasting spend, and making cost-effective operational decisions aligned with program goals. - Proven ability to collaborate cross-functionally and influence stakeholders to drive strategic and operational decisions. - Leadership capabilities, including the ability to mentor, influence, and drive team or matrix performance. - Ability to manage complex projects, prioritize competing demands, and solve problems in a fast-paced environment. Requirements - Bachelor of Science/Master of Science degree in a related discipline, or equivalent work experience. Advanced degree is preferred. Benefits - Eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance. - Retirement savings plan. - Flexible paid vacation.