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Central Monitoring Lead/Senior Clinical Data Risk Analyst - Client Dedicated
165450
Posted:
01/05/2025
- Competitive
- Warsaw, Poland
- Permanent
Senior Clinical Data Risk Analyst
About the role
As a Senior Clinical Data Risk Analyst you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
We are currently seeking a Senior Clinical Data Risk Analyst to join our diverse and dynamic team. As a Senior Clinical Data Risk Analyst, you will play a pivotal role in identifying, assessing, and mitigating risks associated with clinical trial data. You will contribute to the advancement of innovative treatments and therapies by ensuring data integrity and compliance through proactive risk management strategies and analytical insights.
Primary Location: Poland (remote/hybrid)
What you will be doing:
You should have:
About the role
As a Senior Clinical Data Risk Analyst you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
We are currently seeking a Senior Clinical Data Risk Analyst to join our diverse and dynamic team. As a Senior Clinical Data Risk Analyst, you will play a pivotal role in identifying, assessing, and mitigating risks associated with clinical trial data. You will contribute to the advancement of innovative treatments and therapies by ensuring data integrity and compliance through proactive risk management strategies and analytical insights.
Primary Location: Poland (remote/hybrid)
What you will be doing:
- Leading the evaluation of clinical trial data to identify potential risks and trends that may impact study outcomes.
- Leads Risk Assessment and central monitoring observation review discussions with the clinical study team. Supports the team in assessment and mitigation of centralized monitoring observations to identify potential issues and risks occurring during study conduct.
- Reviews study-level KRIs, QTLs, statistical monitoring data outputs in aggregate across sites, regions, and countries.
- Contributes to activities that define, deliver, and optimize the centralized monitoring capabilities and processes.
- Develops the central monitoring and data surveillance plan, incorporating feedback and discussion with the study team to capture the study requirements for the study-specific central monitoring and data surveillance strategies.
- Facilitates and contributes to key activities of study start up, conduct, and close-out, including: Risk assessment, identification of critical data and critical processes, Key Risk Indicator (KRI) identification for study level centralized monitoring, and definition of appropriate thresholds to effectively monitor study progress around the associated KRIs and QTLs.
- Acts as the study-level primary contact, and subject matter expert for the centralized statistical monitoring tool.
- Collaborating with cross-functional teams to develop and implement risk mitigation strategies that enhance data quality and integrity.
- Overseeing the analysis of data discrepancies and inconsistencies, providing insights to inform decision-making processes.
- Providing guidance on best practices for data governance and compliance within clinical research.
- Establishing partnerships with stakeholders to ensure alignment on risk management processes and data quality standards.
You should have:
- Advanced degree in a relevant field such as biostatistics, data science, or life sciences.
- Extensive experience in clinical data analysis, with a focus on risk assessment and management.
- Expertise in Risk-Based Quality Management (RBQM) methodologies.
- Demonstrated central monitoring analytical skills in multiple development programs, inclusive of all activities from program inception to regulatory submission.
- Experience in CluePoints is a plus.
- Strong computer skills, including database management software, data analysis & reporting tools, project management tools, etc.
- Strong leadership skills and a proven ability to work collaboratively in a matrix environment.
- Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive change in a complex organization
amelia koncki
Client Associate