• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes • Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards • Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures • Build and manage strong relationships with trial investigators and stakeholders • Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines • Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management

• The LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level • Managing the consistency of Local Trial Management duties and processes • Serve as the country-level single point of contact on the study for internal partners • Manage and oversee Central IRB and other local vendors, including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable • Execution of local milestones from feasibility through study close out • Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM) • Inspection Readiness and AQR at the country level • Close collaboration with the assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training, where necessary • Efficient communication with the Clinical Trial Managers, Clinical Operations and the Global Trial Leader to oversee trial excellence • Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables • Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership

Role Description Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: - Field monitoring of studies and data collection for clinical trials. - Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form. - Determining if clinical trial/study subject documentation is within parameters of study hypothesis. - Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. - Developing and delivering technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements. - Training and proctoring new employees on trial and study related activities. - Acting as a mentor to new or junior level employees. - Providing oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff. - Supporting study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements. - Contributing to the development of clinical protocols, informed consent forms, and case report forms. - Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition. - Verifying trial/study data, including maintaining appropriate regulatory documents both internal and external. - Auditing to ensure the site has the appropriate regulatory documentation to conduct the trial/study. - Ensuring source documentation is properly recorded. - Editing/amending informed consent documents. Qualifications - Bachelor's Degree or equivalent in related field with 5 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria. - Ability to travel up to 75% domestically. Requirements - Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification) (Preferred). - Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills (Preferred). - Demonstrated problem-solving and critical thinking skills (Preferred). - Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery (Preferred). - Excellent understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise (Preferred). - Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting (Preferred). - Technical writing skills (protocols, CRF development, study tools) (Preferred). - Ability to communicate and relate well with key opinion leaders and clinical personnel (Preferred). - Experience in training new hires (Preferred). Benefits - Competitive salaries. - Performance-based incentives. - A wide variety of benefits programs to address the diverse individual needs of our employees and their families. Company Description Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement: Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Role Description The Principal Biostatistician is responsible for providing statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes. Job Responsibilities - Support Safety Analytics with ADaM/TFL standard development of safety deliverables, including specialty areas such as Hypersensitivity, Injection/Infusion Site Reaction. - Support Safety Analytics and the study team on the delivery of Patient Profile display for Hepatic or other areas. - Provide ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs. - Interrogating root cause of issues identified during ADaM/TFL/Interactive package review. - Providing statistical leadership and support for safety analyses for Phase 1/2/3 trials. - Collaborate with multi-disciplinary project teams to establish project objectives and timelines. - Participating in study design discussions, including protocol development. - Write the statistical sections of clinical trial protocols. - Reviewing CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed. - Developing and reviewing statistical analysis plans and TFL templates. - Monitor internal and CRO project activities including timelines, deliverables, and availability of resources. - Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise. - Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc. - Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements. - Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures. - Perform exploratory safety analyses. - Perform validation of analysis variables and statistical outputs. - Interpret study results and review reports of study results for accuracy. - Present, communicate and interpret safety analyses to study teams. - Support exploratory analyses. - Participate in pre-IND or NDA activities. Qualifications - PhD in Statistics, Biostatistics, or related field with 3+ years industry experience. - MS in Statistics, Biostatistics, or related field with 5+ years of industry experience. - At least 2 years of Phase 1, 2 and 3 clinical trial experience. - Strong experience reviewing ADaM datasets and TFLs (standard and customized output review). - Ability to follow data specifications and programming specifications and provide clear, actionable review comments. - Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors. - Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward. - R/SAS programming skills. - Demonstrated ability to work pro-actively and independently. - Able to effectively communicate his/her ideas and to manage programmers in a constructive manner. - Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards. - Experience with CDISC SDTM and CDASH. Desired Experience - Leading DSBM or DMC for biostatistics. Benefits - Home-based remote working opportunities. - Work/life balance as well as flexible schedules. - Collaborating with motivated, high-performance, statistical and research teams. - Technical training and tailored development curriculum. - Research opportunities that match your unique skillset. - Promising career trajectory. - Job stability: long-term engagements and re-deployment opportunities. - Focus on bringing new therapies to market rather than project budgets and change orders. - Experience with regulatory submissions. - Engaging, fast-paced environment. - Good work-life balance.