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Senior Lead, Data Analysis
3 weeks ago
Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach
Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM
Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
RBQM Meetings: lead facilitation of monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverables
Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies
Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation
Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance
Sponsor Engagement and Communications: support discussions with Sponsors around risk management and proactive data cleaning
Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience
Minimum 5 years experience in clinical monitoring, clinical trial management or equivalent
Working knowledge of ICH GCP guidelines and the clinical development process
Highly effective oral and written communication skills with the ability to communicate effectively with project team members
Excellent organizational and time management skills
Excellent written and spoken English, including strong grammar and scientific vocabulary skills
Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk
Proficiency in statistical analysis and data monitoring tools.
Demonstrated experience with integrated risk planning & management
Ability to mentor junior team members
CRO experience as a Central Monitor
Statistical analysis and data monitoring
Risk assessment and mitigation
Report writing and presentation
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If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
