Clinical Project Manager

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