Clinical Project Leader at Fluxtek Solutions Inc | Torre
Clinical Project Leader
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Fluxtek Solutions Inc

Clinical Project Leader

Fluxtek Solutions Inc
Emma
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You'll advance medical device innovation by leading clinical trials from plan to closeout.
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Full-time

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Shared by
Cata Morales
 about 2 months ago

Requirements and responsibilities

Partner with relevant Baxter functions to develop clinical study plan for each project including timelines and budgets for the clinical programPrepare directly or facilitate preparation of study documentation including protocols, case report forms, informed consent, enrollment feasibility evaluations, and all relevant internal plans required for studyCRO Management (when applicable): Lead the day-to-day oversight of the CRO personnel plus the project budget, deliverables, and timeline/milestonesSite Activities (either directly or managing others): Identify and assess study sites, conduct investigator meetings and site training, prepare and execute research agreements, and negotiate study budgetsStudy Monitoring (either directly or managing others): Formulate clinical monitoring plan, perform study initiation visits, manage clinical study monitoring resources, oversee standard interim monitoring visits and closeout activitiesDevelop and maintain tracking systems as needed for study management (e.g., screening, enrollment, study completion, serious adverse events, budgets and forecasts, milestones)Required Education: Bachelor's degree in a scientific fieldRequired Skills:Clinical Research Experience: 4–5 years of clinical research experience (including 1–2+ years as a Clinical Project Manager)Regulatory Knowledge: Knowledge of FDA, ICH/GCP, and global regulatory requirementsClinical Trials: Understanding of clinical trial phases (Phase 1–4)Clinical Systems: Experience with clinical systems (EDC, CTMS, eTMF)Project Management: Strong project management skillsCardiac Knowledge: Knowledge of arrhythmias, ECG interpretation, or ambulatory cardiac monitoring systemsData Interpretation: Ability to interpret diagnostic performance metrics (e.g., sensitivity, specificity, PPV/NPV) and translate findings into clinical insightsRisk Assessment: Experience assessing risk/benefit and clinical implications of algorithm performance differencesAlgorithm/Device Knowledge: Familiarity with algorithm-based diagnostics or AI/ML-driven medical devicesRegulatory Validation: Understanding of validation requirements for medical devices (e.g., EU MDR, FDA expectations)
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