Project Leader
Contract W2
8 Months
No Travel Required
On-site
$90 - $95/hr
Medinext Global LLC
Fitment
Dice Job Match Score™
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Job Details
Skills
- Clinical
- Data Analysis
- Program management
- Regulatory
Summary
Position Description:
Position Title - Project Leader
Job Location - Skaneateles Falls, NY, USA
Bill Rate Range - $90 to $95
Estimated Duration (In Months) - 8
Work Model - Onsite
Must have Skills/Attributes - Clinical, Data Analysis, Program management, Regulatory
Shift - Monday to Friday, 8 to 5
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 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)
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 91173643
- Position Id: 8981486
- Posted 1 day ago
Company Info
With years of combined experience in medical billing, revenue cycle management, and healthcare IT, Medinext Global LLC brings a unique dual-domain expertise to help providers run smarter, more compliant operations.
To become the most trusted partner in Healthcare RCM, IT Consulting, and Global Talent Services, enabling organizations worldwide to reach new levels of efficiency, security, and success.
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