Central Monitor II - Romania/Poland/Serbia/Spain - FSP

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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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. We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success. As the company that conducts vital clinical studies for sponsors, including the world's leading biotech's and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects. You will work from your home office base, supporting studies within their country or region. 'Manageable sites, manageable protocols' is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life. Accountabilities: Central Monitoring Execution: 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. Risk Identification and Management: 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 Data Review and Reporting: 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. Data integrity and quality through Collaboration: 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. A

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