Overview
AbbVie is an equal opportunity employer and is dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. AbbVie’s policy is to employ qualified persons of the greatest ability with a fair and inclusive recruitment process without discrimination. If you have accessibility requirements, please let our team know by emailing or speaking with your Recruiter so we can accommodate your needs.
Job description text is provided below for the Senior Central Monitor role, including responsibilities, qualifications, and related information.
Job Description
The Senior Central Monitor is at the heart of AbbVie’s end-to-end Risk Based Quality Management model. This role oversees centralised monitoring activities for clinical trials, ensuring data quality and patient safety across multiple studies. The role analyzes site performance metrics, detects risk signals, and collaborates with cross-functional teams to proactively address potential issues. This position requires strong expertise in clinical data review, central statistical monitoring tools, and risk-based monitoring strategies. You will provide guidance to junior monitors, coordinate escalations, and contribute to continuous process improvement initiatives. The Senior Central Monitor acts as a key contact for study teams and external partners, ensuring regulatory compliance, company SOPs, and industry best practices. This is a highly collaborative and analytical role for those passionate about clinical trial quality and operational excellence.
Key Duties and Responsibilities
- Review protocol and ensure Integrated Data Review Plan is updated for the central monitor role within the study, ensuring key critical data is included in the plan aligned to the central monitor role.
- Inspect near-real-time aggregate clinical and operational data from multiple sources (eCRF, vendor data, digital health/wearables, etc.). Utilize data analytics and visualizations to uncover insights and identify complex patterns.
- Use Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) to identify significant issues and emerging risks at the study site, program, country.
- Document detected issues or emerging risks clearly, including situation, significance, implications, and required actions.
- Communicate findings per planned process to ensure cross-functional stakeholders, including senior leaders, have a common understanding to drive appropriate follow-up actions.
- Provide information to primary site monitors to enable effective collaboration with site staff and investigators.
- Collaborate with the Study Team, cross-functional departments, and senior leaders to pursue quality objectives.
- Participate in Health of Study and Risk Management meetings.
- Coach and mentor junior and peer Central Monitors and advise managers on challenges faced.
- Contribute to RBM system development and testing at the study level to ensure system quality.
- Act as an RBQM champion across AbbVie, supporting RBM processes within cross-functional teams across R&D; portfolio.
- Report adverse events within 24 hours per AbbVie policies and procedures.
- Adhere to AbbVie safety programs and maintain a safe work environment; comply with internal codes of conduct and compliance processes.
Qualifications
- Bachelor’s degree in a related field (life sciences, risk-based discipline).
- Minimum of 5 years of clinically related or data trend analysis experience; at least 4 years in clinical research monitoring.
- Experience in RBQM or risk-based environments.
- Knowledge of regulatory requirements, ICH/GCP guidelines related to clinical trials; study management, data management, and regulatory operations.
- Therapeutic area experience preferred in Neuroscience, Oncology, Immunology, Eye Care, Medical Aesthetics, Women’s Healthcare, or GI.
- Strong ability to evaluate large data volumes from multiple sources, perform root cause analysis, and communicate findings to stakeholders.
- Proactive problem-solving, contingency planning, and quick learning in new problems.
- Strong English communication skills; excellent interpersonal, planning, and organizational abilities; able to work independently.
- Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams).
Flexibility and Availability
In line with Australia’s "Right to Disconnect" legislation, AbbVie respects employees’ right to refuse contact outside working hours unless required for collaboration in a global, matrixed environment. Some meetings may occur outside standard hours; flexibility is valued to support effective teamwork.
Additional Information
- AbbVie practices All For One AbbVie, decides smart and sure, stay agile and accountable, communicates clearly and courageously, and makes possibilities real through curiosity and continuous improvement.
Code of Conduct & Business Integrity
- AbbVie commits to high integrity and ethical standards in all business dealings.
- All employees are responsible for maintaining the Company’s reputation for conduct and compliance with the law.
- Soliciting or accepting bribes is grounds for immediate dismissal.
AbbVie is an equal opportunity employer and is committed to operating with integrity, innovation, and inclusion. Equal Prospect Employer/Veterans/Disabled. For more information, visit the AbbVie join-us pages and reasonable accommodations information.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Other
Industries
- Pharmaceutical Manufacturing and Biotechnology Research
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📌 Senior Central Monitor
🏢 Abbvie
📍 City of Sydney