Senior Central Monitor
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve responsible health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion.
Job Description
The Senior Central Monitor is at the heart of AbbVie's end-to-end Risk Based Quality Management model. This critical role oversees centralised monitoring activities for clinical trials, ensuring data quality and patient safety across multiple studies.
- Review protocol and ensure Integrated Data Review Plan is updated for the central monitor role within the study.
- Inspect near-real-time aggregate clinical and operational data from multiple sources.
- Use Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) to identify significant issues and emerging risks.
- Clearly document the detected issue / emerging risk.
- Communicate findings as per planned process to ensure that all cross-functional stakeholders have the same understanding of the issue / emerging risk.
- Arm the primary site monitor with important information that will enable AbbVie to be the clinical partner of choice.
- Work collaboratively in the pursuit of quality with the primary site monitor, the Study Team, cross-functional departments and senior leaders.
Qualifications
- Bachelors degree in related field, may include life sciences, risk-based discipline.
- Minimum of 5 years of clinically related or data trend analysis experience; at least 4 years of clinical research monitoring.
- Experience working in an RBQM-model or similar experience with risk-based environment required.
- Demonstrated current in-depth knowledge and understanding/or willingness to learn of appropriate therapeutic indications, regulations, and ICH/GCP guidelines.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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📌 Senior Central Monitor
🏢 Abbvie
📍 City of Sydney