• Independently coordinates assigned study activities in accordance with study protocols, SOPs, and applicable regulatory requirements. • Screens potential research participants for eligibility, documents inclusion/exclusion determinations, and escalates complex eligibility questions as needed. • Manages scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities with minimal supervision. • Collects, reviews, and enters study data accurately and in a timely manner using electronic data capture (EDC) and other study systems. • Maintains complete and audit-ready study files, including regulatory binders, participant records, and tracking logs, in compliance with GCP and company standards. • Conducts or supports informed consent discussions, ensuring proper documentation, version control, and filing. • Serves as a primary point of contact for research participants and caregivers, addressing routine questions, coordinating logistics, and escalating clinical or protocol-related issues appropriately. • Prepares for and supports sponsor, IRB, and regulatory monitoring visits, including responding to document requests and resolving queries or action items. • Tracks and reports study progress metrics such as enrollment, retention, deviations, and visit completion. • Identifies potential operational issues and proactively communicates risks, barriers, or improvement opportunities to research leadership. • Collaborates closely with investigators, care coordinators, and cross-functional teams to ensure a high-quality, patient-centered research experience. • Supports onboarding and informal mentoring of junior research staff as appropriate.

• To provide expert statistical input to Phase I-IV global clinical trials, including the design of clinical trials (protocol, sample size, randomisation, etc) and the production and review of analysis and reporting deliverables (including statistical analysis plans) on behalf of and/or in conjunction with Aixial Group clients. • Creation and QC of study specifications for ADaM datasets, and statistical programming and QC of ADaM datasets for global Phase I-IV trials. • Statistical programming and QC of tables, listings and figures for global Phase I-IV trials. • Responsible for the quality and timeliness of statistical deliverables. • As lead Statistician, to be primarily responsible for all statistical activities on allocated studies including planning and coordination of activities for assigned statistical team members.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Clinical Specialist About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with a high employer contribution - Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. - Acts as a clinical interface between the medical community and the business. - Demonstrates ability to build and sustain credible business relationships with customers and shares product expertise accordingly. - Provides engineering, sales, education and clinical support in response to field inquiries on as-needed basis. Demonstrates a thorough command of all EP products, related product and technical knowledge, trends and players. - Develops, leads and/or facilitates trainings and other programs on EP products to healthcare professionals. - Provides insight, guidance, and feedback to management on market feedback and components of next generation of products. - Provides regional EP procedural case coverage. - Provides additional back-up support to EP Sales Representatives in the following areas: - Sales support; - Regional training seminars; - Clinical studies/data collection; - Trouble Shooting; and, - New product in-service training to physicians, nurses and sales representatives. - Continuously develops engineering, sales and technical skills relative to the overall Arrhythmia Management strategy, including learning opportunities via Sr. Sales personnel and management. - Assists Training and Education departments with advanced educational seminars, and the preparation of educational materials. - Assists Sales with advanced product demonstrations to visiting physicians and sales personnel. - Remains current on developments in field(s) of expertise, regulatory requirements, and a good working knowledge of company and competitor products, markets, and objectives as well as industry trends. - Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. - Performs related functions and responsibilities, on occasion, as assigned. Required Qualifications - Bachelor’s degree in Bio-Medical Engineering, related field or equivalent healthcare experience required. - Requires ability to become certified on EP products. - A minimum of two years increasingly responsible experience in the cardiac pacing and related industries. - Demonstrated knowledge of cardiology, electro-physiology, or cardiac electro-physiology procedures. - Familiarity with cath lab and operating room procedures and protocol. - Demonstrated advanced knowledge of cardiac pacing systems is also necessary. - Must apply engineering skills and abilities to interpret and solve complex clinical problems. - Must have comprehensive written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to meet deadlines. - Must have the ability to concentrate on detail and work independently. - Must be able to work effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals; must be capable of coordinating multiple assignments simultaneously and effectively. - Must possess comprehensive personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc., to develop presentation materials. - Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s). Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $61,300.00 – $122,700.00In specific locations, the pay range may vary from the range posted. JOB FAMILY: Support Services DIVISION: EP Electrophysiology LOCATION: United States of America : Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 50 % of the Time MEDICAL SURVEILLANCE: Yes SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. • Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. • This may include accompanying CRA team members to sites for observation or conflict resolution. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. • Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. • Ensures access and audit trail reviews are conducted as required. • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. • Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. • Document requested revisions and approvals in CTMS. • Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. • Provides solutions for obstacles in protocol execution and site management. • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. • Supports Inspection Readiness for clinical trial management scope. • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.