Associate Site Report Specialist

Project Role: Associate Site Report Specialist Work Experience: 3+ Years Work location: India Work Mode: Remote Must Have Skills: Onsite experience with 60+ trialsJob Overview:The Central Monitoring Lead (CML) provides leadership and oversight of centralized monitoring activities to ensure subject safety, data integrity, regulatory compliance, and delivery of clinical trial objectives as per sponsor and contract requirements. The role partners with clinical, project, analytics, quality, and therapeutic teams to identify and mitigate risks, optimize monitoring strategies, and ensure audit‑ready study execution.Key Responsibilities:Lead centralized monitors and CMAs across assigned studies (start‑up to close‑out)Provide clinical and functional oversight in line with ICH‑GCP, SOPs, protocol, and COPDrive risk‑based monitoring, KRIs, site metrics, trend analysis, and issue escalationOversee subject‑level data review, site report review, and quality checksSupport monitoring strategy, advanced analytics, and operational insightsManage study finances, investigator payments, and project systemsLead cross‑functional coordination, stakeholder communication, and client interactionsEnsure audit readiness, CAPA implementation, and quality initiativesMentor and manage project teams; act as SME and trainerQualifications & SkillsStrong knowledge of clinical trial conduct, centralized monitoring, and regulationsExperience with analytics, clinical systems, and medical dataExcellent communication, leadership, and stakeholder management skillsAbility to manage multiple studies, risks, and timelinesEducationBachelor’s in Clinical/Life Sciences, Nursing, Allied Health, or related fieldOR Master’s in Science

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