• Serve as the quality lead for assigned clinical studies and programs, providing guidance on GCP compliance and quality expectations. • Lead and support the Study Risk Assessment (SRA) process and proactively engage in inspection readiness activities. • Conduct and manage investigations, root cause analyses, and the development and oversight of CAPAs and Effectiveness Checks. • Collaborate with stakeholders to evaluate and escalate quality risks, and contribute to the development of mitigation strategies. • Partner with internal and external teams to ensure appropriate documentation, risk management, and audit/inspection response planning. • Support audit planning and regulatory inspection preparation, contributing to inspection management strategies and coordination. • Participate in cross-functional and process improvement initiatives to enhance quality system effectiveness across RD&M. • Review and approve controlled documents, CAPAs, and SOPs in alignment with quality standards and regulatory requirements.

• Lead safe offshore site operations, ensuring work is delivered to quality standards, on schedule, and within budget. • Track key performance indicators, report progress and deviations, and implement mitigation actions where required. • Champion the GE Vernova Way by promoting innovation, Lean practices, accountability, and a one-team culture. • Lead implementation of response plans in line with Operator and GE policies, including support for incident investigations. • Oversee all offshore wind operations-related activities across European wind farms, with accountability for SQDC performance. • Serve as the primary contact for customer representatives and prepare monthly customer reports. • Coordinate administrative and planning activities, including technician levels, service schedules, requisitions, documentation, and availability tracking. • Lead the Production-Based Availability operational plan to strengthen collaboration with the operator and improve availability. • Monitor production-based availability metrics and ensure accurate reporting to customer and GE Vernova management. • Approve rotation plans and resource deployment to support scope delivery and manage risks to SQDC targets. • Drive continuous improvement, knowledge retention, and feedback loops across the business. • Lead issue resolution, process improvement, and cross-functional business initiatives. • Support recruitment, talent development, and technician competence development. • Ensure all resources, including technician authorization panels, are in place to support site operations. • Lead development and continuous improvement of systems, processes, and Standard Operating Procedures. • Support budget creation and ensure adherence to approved budgets. • Collaborate with support functions to establish supplier agreements and contracts. • Define clear roles and responsibilities across all capabilities in scope to ensure successful site delivery.

Role Description The American Heart Association has an excellent opportunity for an Operations Manager, Clinical Studies in the Clinical Research Department. This position can be home-based and is a full-time, benefits eligible, grant funded opportunity. Current funding will expire on October 31, 2027, with the potential for funding renewal and role extension beyond that date. The Manager, Operations is responsible for the day-to-day management of Clinical Research Department operations, including: - Budget management - Contract management - Reporting This position reports to the Senior Manager of Operations and will support efforts to establish and implement best practice operational standards. Additionally, this position will support the Senior Director of Clinical Studies in special projects related to department and team objectives as needed. Responsibilities - Responsible for and handling operations, such as accounting, expense reporting, and procurement; forming relationships with legal, external vendors, and partners to ensure overall business goals are achieved. - Develop reports, trackers, or assessment tools to ensure compliance, as needed. - Manage departmental contracting processes, including site and sponsor contracts. - Work with American Heart Association legal department to establish and negotiate contract terms for hospitals, practices, sponsors, etc. - Monitor and track process of associated statuses and documents. - Utilize vendor and/or American Heart Association systems (e.g., E1, Optimus, iEnvision, etc.) efficiently and competently to process invoices, contracts, requisitions, and expenses. - Support Senior Manager of Operations to establish budget tracking and reporting across multiple restricted and unrestricted budgets between $50 - 100 million. - Develop, prepare, and distribute monthly reports on variances to project requirements for leadership. - Analyze financial activities from purchasing, contract terms, and vendor invoices against budget. - Provide reconciliation, mentorship, and recommendations. - Act as lead in program budget preparation and facilitation including communicating procedures, distributing, and completing budget templates, training, and overseeing modifications or revisions. - Coordinate with the leadership team for preparation and submission to funding organization or related controls. - Prepare and manage recurring reports to track related fiscal and legal activities. Qualifications - Bachelor’s Degree or equivalent work experience, Master’s Degree preferred. - 3 years of relevant work experience. - Comprehensive experience applying the principles and practices of accounting, financial analysis, budget analysis, and general business administration. - Experience in grant project management, preferably in healthcare space, including clinical trials. - Extensive knowledge of budgeting, financial and reporting processes for service agreements and/or grants. - Proficient in large-scale purchasing, budget projection and planning, variance analysis, and reconciliation requirements. - Ability to analyze financial data and interpret into narrative form. - Excellent in oral and written communications. - Ability to communicate with all levels of American Heart Association staff. - Ability to communicate with technology and non-technology staff. - Ability to concurrently manage multiple projects and reprioritize ongoing work. Preferred Work Experience - 3 years of experience with developing and managing process (and process change) documentation. - 3 years of experience working in a fast-paced, multifaceted environment. - Excels in working against deadlines to provide end product. Compensation & Benefits - The expected pay range will be $70,000 to $85,000. Pay is commensurate with experience; geographic differentials to the pay range may apply. - Performance and Recognition: You are rewarded for achieving success through annual salary planning and incentive programs; eligibility for an incentive program is based on the type of position. - Benefits: We offer a wide array of benefits including medical, dental, vision, disability, and life insurance, along with a robust retirement program that includes an employer match and automatic contribution. - Professional Development: You can join one of our many Employee Resource Groups (ERG) or be a mentor/mentee in our professional mentoring program. - Work-Life Harmonization: The Association offers Paid Time Off (PTO) at a minimum of 16 days per year for new employees, increasing based on seniority level, along with 12 paid holidays off each year. - Tuition Assistance: We support the career development of all employees with financial assistance for further education and career development.

• Daily execution of specialized expertise and depth of technical knowledge in operations • Interpretation of procedures to resolving problems, with mindfulness to how each step and team member contribute to the overall operational execution • Maintain and respond with urgency to all incoming requests of applications operations and end user customers for field assistance