Central Monitoring Expert

3 days ago


Thiruvananthapuram, Kerala, India K3-Innovations, Inc. Full time
Job Summary
The Senior Central Monitor at K3-Innovations, Inc. plays a critical role in ensuring the quality and integrity of clinical trial data. This position involves analyzing trial data, identifying potential risks, and collaborating with cross-functional teams to improve study efficiency.
Key Responsibilities:
Data Quality Oversight: Ensure data accuracy, completeness, and consistency across study sites.
Risk Detection: Utilize statistical methods and analytical tools to identify unusual patterns in data and provide actionable insights for risk-based monitoring strategies.
Cross-Functional Collaboration: Work closely with clinical operations, site monitors, and project teams to address identified risks and ensure compliance with regulatory requirements.
Process Improvement: Develop and refine centralized monitoring processes based on industry best practices and ensure adherence to regulatory requirements and company SOPs.
Qualifications & Skills:
• Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field.
• Minimum 5+ years of experience in clinical research, with at least 2 years in centralized monitoring or risk-based monitoring.
• Strong knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
• Experience working with clinical trial management systems (CTMS), electronic data capture (EDC), and analytical tools.

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