Site Monitoring Lead / Clinical Operations Lead - FSP - Remote

📋 Description

• • As a Site Monitoring Lead (SML) within Parexel's FSP (Functional Service Provider) model, you will play a pivotal role in ensuring the successful execution of clinical trials for a dedicated, key sponsor in the EMEA region. This position is crucial for maintaining the integrity of clinical research, safeguarding patient well-being, and ensuring the reliability of trial data, all while working remotely.
• • You will be a vital member of the global Clinical Trial Team, taking ownership of the strategic planning, implementation, and oversight of all site monitoring activities for your assigned trials. Your primary responsibility will be to ensure that these activities are conducted in strict adherence to the study protocol, sponsor obligations, ICH-GCP guidelines, and all applicable regulatory requirements, thereby guaranteeing inspection readiness at all times.
• • A core aspect of your role involves authoring comprehensive monitoring risk assessments and detailed monitoring plans. These documents will form the foundation for a risk-based approach to site monitoring, ensuring that resources are effectively allocated to areas of highest potential risk.
• • You will be responsible for developing and implementing robust sponsor oversight strategies, enabling proactive identification of trends, early detection of potential safety signals, and timely intervention to address any emerging issues.
• • Collaboration is key in this role. You will work closely with CRO (Contract Research Organization) partners, providing clear direction and oversight to ensure they effectively manage and execute site monitoring activities. This partnership is essential for the efficient delivery of the client's pipeline, demanding accurate planning and seamless execution.
• • Your contribution will directly impact the overall success and timely delivery of your assigned clinical trials, measured against defined milestones and key performance indicators (KPIs). You will be accountable for managing the trial-level planning, implementation, issue resolution, and ongoing oversight of site monitoring operations.
• • A significant part of your responsibility will be to develop and deliver appropriate training on site monitoring best practices to Clinical Trial Managers (CTM) and Clinical Research Associates (CRA). This ensures a consistent and high standard of monitoring across all involved personnel.
• • You will actively monitor the progress of site management and monitoring activities conducted by CRO partners, meticulously reviewing their adherence to ICH-GCP, regulatory requirements, internal SOPs, the trial protocol, and the established quality management and site monitoring plans.
• • Furthermore, you will coordinate the timely cleaning and delivery of clinical trial data, working closely with the broader Trial Team and country-level operations to ensure data accuracy and accessibility for analysis and reporting.
• • This role requires a deep understanding of the dimensions of trial complexity, encompassing protocol design, patient populations, site capabilities, country-specific regulations, and vendor management. Your ability to navigate these complexities will be critical to successful trial execution.
• • By championing a risk-based site monitoring approach and providing expert guidance, you will contribute to the efficient and compliant conduct of clinical trials, ultimately supporting the development of life-changing therapies and reinforcing Parexel's commitment to improving global health.
• • You will be empowered to make critical decisions regarding monitoring strategies and resource allocation, ensuring that trials are conducted to the highest standards of quality and compliance.
• • This position offers the opportunity to work with a leading pharmaceutical sponsor, gaining exposure to diverse therapeutic areas and innovative clinical development programs.
• • Your expertise will be instrumental in identifying and mitigating risks associated with clinical trial conduct, thereby protecting the integrity of the data and the safety of trial participants.
• • You will be expected to foster a culture of continuous improvement, seeking out opportunities to enhance monitoring processes and drive operational excellence.
• • The remote nature of this role provides flexibility while demanding strong self-management and communication skills to maintain seamless collaboration with global teams and sponsor representatives.
• • Ultimately, your success in this role will be measured by your ability to deliver high-quality, compliant, and efficient site monitoring operations that contribute significantly to the sponsor's clinical development objectives and Parexel's mission to improve patient lives.