Senior Lead, Data Analyst

The Senior Lead, Data Analyst will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

• 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 & Quality Thresholds 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 Project Managers
• 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

We are committed to providing a safe and healthy work environment for all employees and promoting equal employment opportunities for all individuals regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.

We strive to foster a positive and inclusive workplace culture that values diversity, equity, and inclusion.