Central Monitor II

• Implement and execute centralized monitoring strategies to support clinical trial oversight
• Conduct ongoing central monitoring analysis of clinical trial data to detect trends and signals
• Work with Data Analysts team in reviewing CM technology outputs and performing an initial investigation of identified risks (e.g., atypical data patterns) to assess their scope and nature in preparation for review with study teams
• As needed, provide input into the data domains required for central monitoring as per the monitoring strategy
• Ensure adherence to risk-based monitoring plans, SOPs, and industry best practices
• Perform data surveillance via the CM platform, identifying potential sites or trial risks in alignment with the IQRMP
• Collaborate with Lead CM and study teams to refine and implement risk-based monitoring plans
• Provide insights and recommendations to enhance trial efficiency and mitigate risks
• Support root cause analysis for identified issues and suggest corrective actions
• Generate and summarize findings within the CM platform and lead the communication of results to study teams and RSL
• Contribute to GCO understanding of impact of findings to data quality
• Support DQT in assessing the criticality and potential root causes of the findings and in defining appropriate follow-up actions
• Support study teams in adopting an approach to clinical trial monitoring that utilizes data and site level information to drive monitoring interventions that have the most potential to impact patients' safety and data quality
• Document findings, escalate critical risks, and support follow-up actions
• Ensure timely documentation of monitoring activities and findings
• Collaborate with cross-functional study teams, including RSLs, Study Leaders, Data Managers, and Clinical Scientific Leaders, to ensure robust risk mitigation plans are in place and effectively executed
• Participate in study team meetings as CTT member and provide data-driven recommendations
• Act as a single point of contact for CM activities for relevant stakeholders for allocated studies and ensure timely communication and coordination
• Act as a key interface between CM, Clinical Study Teams
• The CM develop the Trial Monitoring Plan, ensuring the plan addresses standard as well as trial-specific risks
• Advise on the design and optimization of KRIs and thresholds to enhance the efficacy of Central Monitoring efforts
• Support the continuous improvement of centralized monitoring methodologies
• Ensure adherence to regulatory requirements, SOPs, and GCP guidelines
• Contribute to training and knowledge-sharing initiatives within the Central Monitoring team

• University degree in life science, business or operations
• Fluent in both written and spoken English
• ≥ 5 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs
• Strong clinical experience with excellent understanding of clinical trial development and risk management processes and the management of clinical trials
• Specific central monitoring / monitoring experience are strongly preferred
• ≥ 3 years comprehensive experience in monitoring (central, site), additional experience in clinical data analytics, data management activities or equivalent is preferable
• Specific Central monitoring / monitoring experience (hands-on experience with KRIs review, centralized monitoring and quality tolerance limits -QTLs-) are strongly preferred
• Knowledge of Risk-Based Quality Management (RBQM) and adaptive monitoring principles
• Knowledge of overall clinical trial management process, understanding of the protocol, study associated risks and their significance, and the risk management process
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH)
• Critical thinking and analytical skills to understand/analyze complex data and provide insight into risk signaling, trends, and outliers in data
• Strong analytical and critical thinking skills with the ability to interpret complex clinical and operational data, recognize patterns, and identify potential risk signals or issues
• Strong understanding of clinical metrics and trend analysis
• experience managing operational insight at site level
• Excellent communication and coordination skills
• Strong capability in working in a Global/Country matrixed environment
• Organizational awareness, including significant experience working cross functionally
• Strong technical, analytical and quantitative problem-solving skills
• Technical ability to use the relevant technology and risk-based tools/platforms effectively
• Data and Digital expertise: experience working with e-databases, clinical and/or project management planning and reporting and analytics systems
• Strong project management skill with demonstrated ability to meet timelines
• Proven experience in developing, implementing, and maintaining quality control documentation for remote/central monitoring activities, ensuring data integrity, completeness, and accuracy
• Proven experience in issue identification and resolution, with a proactive and collaborative approach
• Understanding team dynamics: recognizing the diverse talents, personalities, and working styles within a team to create a connected and productive work environment
• Experience in transformation, leveraging AI and analytics
• Ability to understand and navigate diverse cultural contexts
• Extensive knowledge of appropriate therapeutic area preferred

Extensive knowledge of appropriate therapeutic area preferred