Senior Trial Operations Manager
7 days ago
K3-Innovations, Inc. is a leading provider of clinical trials services, dedicated to delivering high-quality data solutions that meet the evolving needs of the biopharmaceutical industry.
Job Description
The Senior Central Monitor will be responsible for overseeing centralized monitoring activities, including data analysis, risk detection, and collaboration with cross-functional teams to improve study efficiency.
Key Responsibilities:
• Analyze trial data to identify potential risks and provide actionable insights for risk-based monitoring strategies.
• Collaborate with clinical operations, site monitors, and project teams to address identified risks and ensure compliance with regulatory requirements.
• 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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