Posted Aug 18, 2026

Clinical Data & Operations Manager

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Why Join iMDx At Insight Molecular Diagnostics (iMDx), our mission is to democratize access to molecular diagnostic testing. At our heart, we are a science-driven organization focused on giving clinicians and researchers the diagnostic tools they need to help improve patient outcomes. Join us and be part of a team that’s redefining what’s possible in healthcare. Core Competencies • Clinical Systems Design & Implementation Expertise in designing, developing, and managing clinical trial systems (e.g., EDC, CTMS, eTMF), ensuring optimal functionality, data flow, and user experience. • Data Management & Integrity Strong ability to manage clinical databases, perform quality control checks, resolve data queries, and ensurehigh standardsof data accuracy and reliability. • Project Management & Operational Execution Proven capability to manage timelines, track progress using project management tools, and ensure delivery of projects aligned with quality and operational goals. • Regulatory Compliance & Standards Expertise Deep understanding of GCP, ICH, and regulatory requirements, along with industry data standards such as CDASH and CDISC, ensuring compliant system design and data handling. • Cross-Functional Collaboration & Influence Ability to effectively partner with internal teams, vendors, and study sites, while influencing stakeholders and driving alignment without direct authority. • Analytical Thinking & Continuous Improvement Skilled in analyzing data trends,identifyingrisks, and leading process improvements and innovation initiatives to enhance clinical data workflows and system performance. Professional Experience • Provide project management and operational support to clinical project teams, ensuring alignment with quality standards, timelines, and project specifications • Set up,maintain, and update clinical databases, including supporting data query resolution and data integrity efforts • Perform quality control checks and support study initiation activities to ensure accuracy and completeness of clinical data • Communicate effectively with study sites, trial teams, and external vendors to support study execution • Establish andmaintainmethodologies for the design and development of clinical trial systems • Ensure system designscomply withdata management standards and protocol requirements whileoptimizingfunctionality, user experience, and data flow • Lead the design, implementation, and integration of clinical systems (e.g., EDC, CTMS, eTMF), including system enhancements and updates • Utilize project management tools to track study progress and plan systems-related activities • Proactivelyidentifyrisks to timelines or quality and develop mitigation strategies • Collaborate cross-functionally with internal teams, vendors, and study centers to achieve program and study objectives • Ensure compliance with federal and local regulations, GCP, ICH guidelines, and organizational quality standards; stay current with evolving regulatory requirements • Drive cross-functional innovation and process improvement initiativesimpactingdata and clinical workflows • Maintain and support current and legacy systems, including enhancements and development of ad hoc queries and reports • Analyze data toidentifytrends, generate insights, and support data-driven decision-making • Write, update, and maintain system requirements and application specifications What You Bring To The Table • Bachelor’s degree in business, management information systems, computer science, life sciences, or a related field; Master’s degree preferred • Minimum of 3+ years of clinical technology experience • Experience with industry-standard design and development tools • In-depth knowledge of clinical trial processes, functions, and key stakeholders • Strong understanding of CDASH and CDISC data standards • Proventrack recordas a key contributor to organizational initiatives and growth • Demonstrated ability to influence stakeholders without direct authority • Experience coaching and mentoring within a matrixed environment • Strong communication and analytical skills • Foundational ability to perform data analysis and implement data-driven solutions Physical Demands • Standing, sitting, walking, bending, reaching, manual manipulation, and lifting 25 pounds. • Ability to have full-body movement • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for at least 50% of a typical working day. • Ability to travel 15% domestically and internationally ifrequired. Job Scope, Additional Duties, and Employment Status: This job description is intended to provide a general overview of the position and does not include all duties, responsibilities, or tasks that may be assigned. The scope of this role may change at any time based on organizational needs, business priorities, or operational requirements. Employees may be required to perform additional duties outside of the general scope of this position as assigned. Employment with the Company is on an at-will basis, meaning either the employee or the Company may terminate the employment relationship at any time, with or without cause or notice, subject to applicable law. Probationary Period: Employment is subject to an initial 90-day probationary period, during which performance, conduct, and overall role fit will be evaluated. Continued employment beyond this period is contingent upon satisfactory performance and alignment with organizational expectations. Why Wait? Apply Today! At iMDx, every role has a purpose, and every team member plays a part in changing lives. Your skills, ideas, and passion could help shape the future of precision medicine—making life-changing healthcare accessible to people everywhere. If you’re ready to do work that truly matters, we’d love to hear your story. Join a team of innovators, problem-solvers, and collaborators who turn complex science into clarity and impact. This is your moment. Don’t wait—apply now and be part of something extraordinary. Together, we can create the future of healthcare