Senior Central Monitor

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Central Monitor based in the United States. The Senior Central Monitor plays a key role in supporting the successful execution of clinical trials through centralized monitoring and data-driven oversight. You will collaborate with clinical monitoring teams and cross-functional stakeholders to identify risks, track study performance, and support quality outcomes. The role involves reviewing centralized data, generating reports, and contributing to risk assessments throughout the study lifecycle. You will help ensure clinical trial activities align with regulatory requirements, ICH GCP guidelines, SOPs, and study-specific plans. This is a remote opportunity within a collaborative, regulated clinical research environment. The position offers the opportunity to improve monitoring processes, strengthen study execution, and contribute to the development of efficient clinical trial practices.

Perform remote site monitoring and management activities for assigned projects in accordance with applicable regulations, ICH GCP guidelines, SOPs, and study plans. Support clinical monitoring teams in implementing study strategies, initiatives, processes, and standards to promote consistent, efficient, and high-quality trial delivery. Collect, analyze, and organize study data and generate reports covering areas such as recruitment, enrollment, drug supply, site payments, and other trial performance indicators. Support data risk assessments and centralized monitoring activities throughout the study lifecycle. Maintain communication with clinical sites and relevant internal and external stakeholders as needed to support study execution. Assist with document collection, visit preparation, study data review, and other monitoring activities. Contribute to the development of tools, workflows, and processes designed to improve project efficiency and measurable outcomes. Maintain compliance with applicable quality, regulatory, and clinical research requirements. Prioritize multiple activities, proactively manage assigned responsibilities, and complete deliverables within established timelines. Perform additional project-related duties as required. Requirements Bachelor’s degree preferred; candidates without a formal degree may be considered based on comparable training, experience, and job-specific qualifications. At least 3 years of experience in study coordination, in-house monitoring, or relevant experience within the biotechnology, pharmaceutical, or another regulated industry. Working knowledge of clinical trial execution processes and centralized monitoring practices. Familiarity with systems such as Electronic Document Management Systems (EDMS), Electronic Data Capture (EDC), and Clinical Trial Management Systems (CTMS). Understanding of general quality assurance concepts and practices. Strong organizational skills and exceptional attention to detail. Excellent written, verbal, and interpersonal communication skills, with the ability to collaborate effectively across internal and external teams. Ability to manage multiple priorities, work proactively, and operate effectively within established procedures. Ability to contribute to process improvements and develop practical solutions that increase project efficiency. Experience with the CluePoints Risk-Based Quality Management (RBQM) system is desirable. Experience in Long COVID and/or pulmonary clinical research is a plus. Benefits Fully remote work opportunity within the United States. Collaborative environment supporting innovation, professional development, and cross-functional teamwork. Opportunities to contribute to clinical research and support the development of new therapies. Inclusive workplace focused on diversity, equity, belonging, and employee empowerment. Opportunities to develop expertise in centralized monitoring, clinical data review, risk-based quality management, and clinical trial operations. Hybrid flexibility may be available for employees located within a reasonable commute of an office, subject to manager agreement. Employment benefits and compensation are provided according to the applicable role and employment terms.

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