Associate Centralized Monitoring Lead - sponsor dedicated (Hybrid/Home-based) Bellville, South Africa | Full time | Hybrid | R Lead the execution of centralized monitoring activities at multiple sites and studies from initiation through to closeout. Ensure that work, clinical study management and project deliverables are on time and in accordance with SOPs, policies, Good Clinical Practice and regulatory requirements. Provide centralized monitoring support across projects, review structured clinical data and ensure readiness of patient information for review, define metrics and timelines, facilitate efficient site visit reviews and maintain quality standards. Essential Functions Review Central Monitoring KRIs, endpoint analyses, QTLs, and other analyses per the study‑specific Central Monitoring Plan. Minimum 1.5 years of Central Monitoring or risk‑based quality management experience. Collaborate effectively with the study team. Manage assigned sites and perform subject‑level data review independently for multiple studies. Perform remote monitoring visits as required. Investigate subject‑level data discrepancies with sites to determine accuracy. Conduct study‑specific analytics and contribute to new analytics proposals. Provide operational insights and complete study/site metric trending and action plans. Support Clinical Study teams and provide inputs to improve processes and manage escalation. Oversee oversight on clinical deliverables per protocol and SOPs. Mentor central monitors and CMA associates. Act as subject‑matter expert on one or more CMS specific activities. Lead study‑level initiatives such as process enhancements and serve as point of contact for internal CM team. Manage IP for assigned study and identify risk and mitigation. Maintain accurate documentation of study tools and templates. Maintain internal systems, databases and reporting tools for project information. Manage triggers and prepare i‑site packs for sites and countries. Conduct periodic review of site KRIs and historic performance per Central Monitoring Plan. Recommend and review corrective actions for site performance. Establish and maintain effective project/site level communications. Prepare and present reports to leadership, mentor associates and attend study team meetings. Act as technical solution specialist point of contact for project teams. Qualifications Bachelor's degree in Clinical, life sciences, mathematical sciences, or related field, or nursing qualification. Minimum of 3 years of relevant work experience or equivalent combination of education, training and experience. Experience in clinical research preferred. Good knowledge of clinical trial conduct and regulatory requirements (ICH GCP, local laws, regulations). Strong clinical system expertise. Excellent written and verbal communication skills and command of English. Results‑oriented and detail‑focused approach. Understanding of clinical/medical data. Good motivational, influencing and coaching skills. Ability to manage multiple projects and competing priorities. Strong organizational and problem‑solving skills. Demonstrated ability to deliver results within quality and timeline metrics. Ability to work across cultures and geographic locations. Physical requirements: extensive keyboard use, telephone communication, face‑to‑face interaction, and prolonged sitting. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted must be truthful and complete. Any false statements will result in immediate disqualification or potential termination. #J-18808-Ljbffr
Associate Centralized Monitoring Lead - Sponsor Dedicated (Hybrid/Home-Based)
IQVIA ARGENTINA
Remote, Remote
Published 10 days ago
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