Clario

• Produce, validate, and maintain submission-ready datasets to support cardiac safety clinical trials, including SDTM ECG (EG) and ADaM ADEG datasets. • Create, test, and maintain SAS programs used to generate and validate CDISC-compliant datasets. • Develop, test, and implement data standards that support cardiac research and regulatory submissions. • Perform double programming and validation activities to ensure the accuracy of statistical analysis datasets. • Generate and interpret compliance checks for CDISC-formatted datasets, including SDTM and ADaM standards. • Support research initiatives by providing programming expertise and analysis results to senior team members and department leadership. • Create electronic submission packages, including Define.xml, reviewer guides, and supporting regulatory documentation in accordance with FDA submission requirements. • Train team members on standard operating procedures, programming standards, and best practices. • Identify and implement process improvements to enhance operational efficiency and data quality. • Manage project timelines and client commitments to ensure on-time delivery of assigned deliverables. • Maintain accurate project status, milestones, and deliverable tracking information. • Contribute to the development and maintenance of SOPs, Standard Work Instructions (SWIs), checklists, playbooks, templates, and quality standards. • Collaborate with cross-functional teams to define programming requirements and support project-level statistical deliverables. • Support onboarding and training of new team members and promote knowledge sharing across the organization.

• Partner with senior leadership to operationalize business strategy and drive execution of high-priority organizational initiatives. • Lead end-to-end delivery of complex, cross-functional programs to ensure alignment with business objectives and enterprise priorities. • Translate strategic goals into actionable plans, key performance indicators, and measurable business outcomes. • Identify risks, dependencies, and opportunities while proactively removing barriers to successful execution. • Oversee a portfolio of operational initiatives, ensuring prioritization aligns with organizational impact and strategic value. • Establish and maintain governance frameworks, reporting structures, and decision-making processes to support program success. • Drive consistency in program and project management practices across teams and functions. • Lead process improvement and standardization initiatives that enhance efficiency, scalability, and operational effectiveness. • Utilize business insights, performance metrics, and analysis to support data-driven decision-making and continuous improvement. • Serve as a trusted advisor to senior leaders and collaborate closely with Product, Finance, Sales, Operations, and other cross-functional partners. • Facilitate stakeholder alignment across competing priorities and organizational objectives. • Communicate program progress, business insights, risks, and recommendations to leadership audiences with clarity and influence. • Define, monitor, and report on key business performance metrics and operational health indicators. • Provide coaching, mentorship, and performance leadership that strengthens team effectiveness and development. • Foster a culture of accountability, collaboration, innovation, and continuous learning.

• Review clinical trial protocols from prospective customers and provide scientific recommendations that support proposal development and customer timelines • Design data collection strategies based on scientific literature, regulatory requirements, industry best practices, and patient/site considerations • Assess project complexity and provide scientific input to solution design and service delivery planning • Develop and deliver scientific content for capability presentations, bid defenses, and customer-facing meetings • Partner with Sales teams during pre-sales engagements to communicate the scientific value of Clario, a part of Thermo Fisher Scientific solutions and services • Support successful project handoff from Sales to Client Services by providing scientific context and proposal guidance • Contribute to training and enablement activities for Client Services teams related to study design, scientific objectives, and industry best practices • Participate in selected post-sales customer meetings and provide ongoing scientific consultation • Support product development initiatives by contributing scientific expertise and market insights • Participate in professional conferences, webinars, publications, abstracts, and white papers that strengthen thought leadership and market visibility • Maintain current knowledge of clinical trial regulations, scientific advancements, industry trends, and emerging best practices • Collaborate with internal and external scientific experts to support client deliverables and advance research initiatives • Contribute to internal research programs and external scientific outreach efforts • Travel approximately 20% as required

• Manage & Coordinate the overall Solutions Design process ensuring that clinical protocols are appropriately mapped to software solutions efficiently, accurately and within project scope • Gather and document requirements and specify design components to support those requirements; Representing the Solutions Design team and provide subject matter expertise within client facing meetings as required • Create and maintain specifications for study-specific implementations of Clario products and services • Ensure consistency between trial data capture, data delivery and database structures • Collaborate with Clinical Systems Translation & Licensing (CSTL) to confirm correct versions of copyrighted questionnaires are implemented • Support Solutions Validation/Quality Control testing by addressing any defects associated with the design in a timely manner • Collaborate with other departments to investigate study issues found beyond the startup phase of the study • Participate or lead parts of internal and external design milestone meetings • Serve as additional delegate representing Solution Design in client audits to describe process flows, standards and best practices • Partner with other Clario teams - such as business Development – to assist in reviewing & analysing proposals & protocols for new studies

Role Description Responsible for providing leadership, governance, industry expertise and best practices to our clients, client projects and the teams dedicated to serving them. Responsible for staff management and directing and managing services for client projects to assure high quality, on-time, and on-budget services while promoting excellent customer service. As a Senior Lead Clinical Project Manager, you will play a critical leadership role in delivering complex, high-impact clinical studies while guiding teams and driving operational excellence. If you are passionate about advancing clinical development and leading high-performing teams, we encourage you to apply. What You’ll Be Doing - Provide oversight of study management and overall project delivery to ensure timelines, scope, and budget objectives are achieved. - Monitor workload and performance of project management staff, adjusting plans and resources as needed. - Proactively identify and mitigate risks across assigned studies and portfolios. - Lead escalation management to resolve internal and external challenges effectively. - Develop and implement problem-solving strategies to address client issues and ensure timely resolution. - Manage stakeholder communication, including clients, internal teams, and senior leadership. - Support Clinical Project Managers in client engagement, study updates, and risk communication. - Coordinate cross-functional teams to ensure successful execution of global clinical projects. - Lead complex, high-visibility studies across start-up, execution, and closeout phases. - Drive process improvements, operational efficiencies, and therapeutic area initiatives. - Mentor and coach team members, supporting professional development and performance management. - Ensure adherence to SOPs, regulatory requirements, and quality standards. - Contribute to business development activities, including client meetings and presentations when applicable. Qualifications - Bachelor’s degree in life sciences, pharmacy, nursing, or related field; Master’s degree preferred. - 5–10 years of clinical trials experience within a CRO or pharmaceutical organization, with strong project management expertise. - Demonstrated leadership experience managing teams, projects, or both in a clinical development environment. - Strong knowledge of drug development processes and regulatory guidelines (e.g., GCP, ICH, FDA). - Proven ability to manage complex, global clinical studies and multiple priorities simultaneously. - Experience in risk management, escalation handling, and stakeholder communication. - Excellent organizational, communication, and problem-solving skills. - Demonstrated ability to coach, mentor, and develop team members. - Proficiency with Microsoft Office tools. - Detail-oriented with strong time management and prioritization skills. - Ability to travel up to approximately 20%, including internationally. - Based in or able to work in the United States (remote or hybrid). Benefits - Competitive compensation. - Medical, dental, and vision coverage. - Flexible and paid time off. - Remote and hybrid work options. - Tuition reimbursement. Company Description At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster. Clario, a part of Thermo Fisher Scientific is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

• Perform interval duration and rate measurements on digital or paper ECGs according to established Standard Operating Procedures (SOPs) • Evaluate and place calipers on digital ECGs and adjusts accordingly using various methodologies • Utilize validated software to convert PNG images to XML files for measurement • Assess waveforms to confirm conversion was accurate • Accurately calibrate scaling of PDF images to collect measurements on paper ECGs • Process cardiac data from continuous Holter recordings • Extract time-point specific 12-Lead ECG extractions • Export XMLs to the designated database for IDM measurement • Evaluate ECGs for safety/alert findings and provide notification to the correct teams as per written procedures • Perform Ambulatory Blood Pressure Monitoring (ABPM) processing • Balance priorities across workflows to analyze Cardiac Safety data in the sequence of priority assigned by operations management • Participate in the Quality Assurance program to demonstrate accuracy, precision, and repeatability • Responsible for reading and applying all job-related SOPs and SWIs • Meet or exceed departmental productivity and quality metrics • Report system performance issues through the correct channels with management and/or IT

• Provide front-line support to customers via phone, email, fax, and other communication channels for assigned product lines • Obtain demographic and visit information for incoming customer interactions and resolve outstanding issues within established service levels • Maintain accurate and complete client, site, and patient information within company databases and systems • Troubleshoot equipment setup, hook-up, transmission, and product usage issues, escalating complex concerns as appropriate • Process re-supply requests, report requests, and product-related inquiries in a timely and efficient manner • Monitor transmission and fax failures and ensure prompt delivery of required information • Identify and report clinical irregularities and system malfunctions to the appropriate stakeholders • Respond to customer inquiries and provide timely technical information and guidance • Collaborate with on-site and remote teams to resolve customer concerns and improve the customer experience • Maintain production, quality, and performance metrics established by Customer Care Management • Provide recommendations regarding product setup, usage, and troubleshooting best practices • Support query resolution activities related to clinical applications and associated programs • Perform additional duties and responsibilities as assigned.

• Collaborate with Project Management and Sales teams to assess scope changes and develop pricing estimates for client projects of varying complexity • Develop Change Orders, client budgets, and proposal documents using Clario and client templates • Deliver high‑quality pricing and proposal documentation within required timelines • Support mentoring and training of junior team members and peer reviews on an as needed basis • Maintain accurate and up‑to‑date budget, pricing, and project information in internal systems • Ensure proper document storage and compliance with departmental guidelines • Coordinate with cross‑functional stakeholders (Sales, Finance, Product, Science) to review fee schedules and determine optimal pricing strategies for complex trials or programs • Analyze and interpret Requests for Proposal (RFPs) and study protocols in collaboration with functional team experts • Support process improvements by contributing to template updates and workflow enhancements • Participate in interdepartmental initiatives, including training related to Change Orders and RFP processes • Perform additional responsibilities and projects as assigned

• Coordinate the overall Solutions Design Process for client studies. • Review clinical trial protocols to identify solution needs and define study-specific eCOA designs. • Gather sponsor requirements and recommend Clario’s best design components to meet study needs. • Create and maintain design specifications ensuring consistency across data capture, delivery, and database structures. • Collaborate with Project Management, Data Management, Product, and Clinical Systems Translation & Licensing (CSTL) to align on requirements and data integrity. • Present solution designs during internal and external milestone meetings. • Support project scoping, change control, and testing processes as needed. • Contribute to product and process improvement initiatives. • Maintain organized documentation and support study tracking efforts.

• Participate in the complete testing process including test planning, design, scripting, execution, review, and test witnessing in a fast-paced, agile development environment • Design, develop, and execute detailed manual test cases, test scenarios, and test data for web and mobile applications • Perform exploratory, usability, and ad-hoc testing to uncover defects beyond scripted test coverage • Create and maintain comprehensive test documentation, including test plans, test cases, and requirements traceability matrices • Contribute to the design, development, and maintenance of automated test scripts where applicable (experience with Playwright or similar tools is a plus) • Execute validation and verification activities to ensure compliance with FDA requirements, GxPs, and 21 CFR Part 11 regulations • Perform functional, integration, system, and regression testing across multiple platforms • Manage bug tracking, defect reporting, and test progress communication through test management tools (JIRA and Xray) • Actively participate in Agile ceremonies including daily stand-ups, sprint planning, retrospectives, and backlog grooming • Work closely with Software Engineers, Product Owners, and cross-functional teams to deliver high-quality software • Review work of less experienced team members and provide mentorship on testing best practices • Communicate effectively with technical and non-technical stakeholders through verbal presentations, written documentation, and progress reports • Maintain meticulous attention to detail and accuracy, committed to excellence in all deliverables • Continuously seek improvements in testing processes, methodologies, and automation coverage • Monitor quality levels, identify root causes of quality issues, and take ownership of resolution • Adhere to company policies, procedures, SOPs, behaviors, and ethical standards at all times • Demonstrate strong problem-solving abilities and proven track record of resolving complex testing challenges • Set challenging goals, prioritize tasks effectively, and overcome obstacles to achieve results • Handle multiple projects with competing deadlines concurrently with minimal supervision • Adapt quickly to changing priorities and respond positively to change • Meet commitments consistently, accept accountability, maintain high personal standards, and stay focused under pressure