We are seeking a skilled and experienced Central Monitor II to join our team.
Key Responsibilities :
Lead the development of Risk-Based Quality Management (RBQM) plans and conduct study risk assessments, ensuring compliance with regulatory requirements and industry best practices.
Perform centralized statistical monitoring, data analysis, and remote centralized data review to detect anomalies and ensure data accuracy, utilizing advanced analytical techniques and tools.
Support monthly RBQM meetings by reviewing study data, documenting findings, and coordinating data cleaning activities, fostering collaboration among cross-functional teams.
Evaluate data quality and integrity through proactive monitoring and timely interventions, identifying areas for improvement and implementing corrective actions.
Collaborate with clinical operations, data management, biostatistics, and other departments to support oversight and management of studies, ensuring seamless coordination and effective communication.
Prepare detailed reports and presentations on monitoring activities and recommendations for sponsors and study teams, effectively communicating complex information and insights.
Requirements :
Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience, with a strong foundation in clinical research, statistics, or a related field.
Minimum 2 years of experience in clinical monitoring, clinical trial management, or a related field, with a proven track record of success and expertise in RBQM principles and methodologies.
Working knowledge of ICH GCP guidelines and the clinical development process, with the ability to apply this knowledge in a practical and effective manner.
Excellent communication, organizational, and time management skills, with the ability to work effectively in a fast-paced environment and prioritize multiple tasks and deadlines.
Strong understanding of RBQM principles and methodologies, with the ability to apply this knowledge in a practical and effective manner.
Proficiency in statistical analysis and data monitoring tools, with the ability to utilize these skills to drive business outcomes and improve study efficiency.
PREFERRED SKILLS :
Risk assessment and mitigation, with the ability to identify and mitigate risks associated with clinical trials.
Report writing and presentation, with the ability to effectively communicate complex information and insights to stakeholders.
Collaboration and teamwork, with the ability to work effectively in a cross-functional team environment and build strong relationships with colleagues and partners.
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Senior Data Analyst • Kanpur, Uttar Pradesh, India
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