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Job Description
Project Leader -
Clinical Research & Program Management Location :
Skaneateles Falls, NY, USA Client:
Baxter Electronics Required Skills & Expertise Clinical Research Data Analysis Program Management Regulatory Compliance Education Requirements Bachelor's degree in a Scientific discipline required Required Qualifications 4-5 years of clinical research experience, including 1-2+ years in a Clinical Project Manager role Strong knowledge of FDA, ICH/GCP, and global regulatory requirements Solid understanding of all phases of clinical trials (Phase I-IV) Hands-on experience with clinical systems such as EDC, CTMS, and eTMF Proven project management and cross-functional coordination skills Knowledge of arrhythmias, ECG interpretation, and ambulatory cardiac monitoring systems Ability to interpret diagnostic performance metrics including sensitivity, specificity, PPV, and NPV, and translate findings into meaningful clinical insights Experience assessing risk/benefit profiles and evaluating clinical implications of algorithm performance variations Familiarity with AI/ML-driven diagnostics and algorithm-based medical devices Understanding of medical device validation requirements, including FDA and EU MDR expectations Self-motivated, proactive, collaborative, and capable of driving initiatives independently Key Responsibilities Partner with cross-functional Baxter teams to develop clinical study plans, including timelines, budgets, and overall program strategy Prepare or oversee preparation of study-related documentation such as protocols, informed consent forms, case report forms, feasibility assessments, and internal operational plans Lead day-to-day CRO oversight, including budget management, deliverables, milestones, and project timelines Identify and evaluate study sites, conduct investigator meetings and site training, negotiate study budgets, and execute research agreements Develop and manage clinical monitoring plans, oversee study initiation, interim monitoring, and closeout activities Ensure successful study closeout, including completion of regulatory documentation, study product disposition, and audit readiness for regulatory authorities Create and maintain tracking systems for enrollment, screening, study progress, adverse events, budgets, forecasting, and project milestones Collaborate with clinical, regulatory, and technical teams to support successful execution of clinical programs and regulatory submissions
