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If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at Central Monitor, home-based and sponsor dedicated, in Spain/Poland/Romania/Serbia. The Central Monitor (CM) plays a key role for Data Surveillance by overseeing and supporting clinical trials through centralized monitoring activities. This role ensures data quality, identifies potential risks, and enhances trial oversight by leveraging data analytics and risk-based monitoring strategies. The CM collaborates with cross-functional teams to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The CM will play a vital role in the study Risk-Based Quality Management process. This role is key to detect any study related risk/issue(s) within the scope of study RBM strategy. The CM will be involved early during clinical trial lifetime, working alongside the Risk Surveillance Lead (RSL) and others to support risk identification, risk assessment, definition of risk oversight measures (ex: Key Risk Indicators - KRIs). The role will have a key responsibility in connecting with the Data Analysts team, ensuring that the Central Monitoring technology is appropriately configured. During trial execution, the CM is responsible for ongoing aggregate Data Surveillance utilizing Central Monitoring technology to monitor data quality, patient safety, and relevant risks, interpreting and contextualizing risk signals for communication to the Clinical Trial Teams (CTTs) as well as to field monitoring teams and Risk Surveillance Team.
Job Responsibility
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
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
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
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
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
Act as a key interface between CM, Clinical Study Teams
Develop the Trial Monitoring Plan
Advise on the design and optimization of KRIs and thresholds
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
Requirements
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) as a Lead CRA or on Central Monitoring position, 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
Nice to have
Previous experience in clinical data analytics, data management activities or equivalent
Specific Central monitoring / monitoring experience (hands-on experience with KRIs review, centralized monitoring and quality tolerance limits -QTLs-)
Extensive knowledge of appropriate therapeutic area