Central Data Integrity Specialist
3 hours ago
As a Senior Central Monitor, you will play a pivotal role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.
Key responsibilities include 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.
Additionally, you will work independently to manage report review and issue escalation for more complex studies and/or portfolios of work. You may also mentor junior colleagues and support the development of processes, procedures, and other documentation to ensure a high-functioning team.
- Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs.
- 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.
The ideal candidate will have a Bachelor's Degree in a relevant field or equivalent experience. A minimum of 5 years of experience in clinical monitoring, clinical trial management, or equivalent is required. Additionally, the ideal candidate should possess working knowledge of ICH GCP guidelines and the clinical development process.
Required skills and qualifications include highly effective oral and written communication skills, excellent organizational and time management skills, and strong understanding of RBQM principles and methodologies.
Proficiency in statistical analysis and data monitoring tools, detail-oriented with strong analytical and problem-solving skills, and demonstrated experience with integrated risk planning & management are also essential.
Excellent written and spoken English, including strong grammar and scientific vocabulary skills, are mandatory.
Responsibilities- Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
- Collaborate closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
- Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
- 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.
At our organization, we strive to provide an inclusive environment where our employees can grow and succeed. We offer a competitive salary range based on experience and opportunities for professional growth and development.
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