What are the responsibilities and job description for the Clinical Project Manager | Skaneateles Falls, NY (ON-SITE) position at Columbus Technology Solutions?
JOB TITLE: Clinical Project Manager
JOB LOCATION: Skaneateles Falls, NY ON-SITE)
EXPERIENCE: 10 Year's
VISA: , -EAD (W2) CAN APPLY.
RATE: $55-$60/HR ON W2
Must-Have Skills
- Clinical
- Data Analysis
- Program management
- Regulatory
Required Education
- Bachelor's degree in a scientific field
Required 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/Google Cloud Platform, and global regulatory requirements
- Clinical Trials: Understanding of clinical trial phases (Phase 1 4)
- Clinical Systems: Experience with clinical systems (EDC, CTMS, eTMF)
- Project Management: Strong project management skills
- Cardiac Knowledge: Knowledge of arrhythmias, ECG interpretation, or ambulatory cardiac monitoring systems
- Data Interpretation: Ability to interpret diagnostic performance metrics (e.g., sensitivity, specificity, PPV/NPV) and translate findings into clinical insights
- Risk Assessment: Experience assessing risk/benefit and clinical implications of algorithm performance differences
- Algorithm/Device Knowledge: Familiarity with algorithm-based diagnostics or AI/ML-driven medical devices
- Regulatory Validation: Understanding of validation requirements for medical devices (e.g., EU MDR, FDA expectations)
- Soft Skills: Proactive, collaborative, and self-driven with a take-charge attitude
Job Responsibilities
- Partner with relevant Baxter functions to develop a clinical study plan for each project , including timelines and budgets for the clinical program.
- Prepare directly or facilitate preparation of study documentation , including protocols, case report forms, informed consent, enrollment feasibility evaluations, and all relevant internal plans required for study conduct.
- CRO Management (when applicable): Lead the day-to-day oversight of the CRO personnel , plus the project budget, deliverables, and timeline/milestones
- Site 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 budgets
- Study 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 activities
- Perform study closeout procedures, directly or through other resources, including accurate completion of critical documents, disposition of study product, and preparation of study sites for regulatory authority audits.
- Develop and maintain tracking systems as needed for study management (e.g., screening, enrollment, study completion, serious adverse events, budgets and forecasts, milestones)
Salary : $60 - $65