Associate Site Report Specialist Full Time

Project Role: Associate Site Report Specialist

Work Experience: 3+ Years

Work location: India

Work Mode: Remote

Must Have Skills: Onsite experience with 60+ trials

Job 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 COP
• Drive risk‑based monitoring, KRIs, site metrics, trend analysis, and issue escalation
• Oversee subject‑level data review, site report review, and quality checks
• Support monitoring strategy, advanced analytics, and operational insights
• Manage study finances, investigator payments, and project systems
• Lead cross‑functional coordination, stakeholder communication, and client interactions
• Ensure audit readiness, CAPA implementation, and quality initiatives
• Mentor and manage project teams; act as SME and trainer

Qualifications & Skills

• Strong knowledge of clinical trial conduct, centralized monitoring, and regulations
• Experience with analytics, clinical systems, and medical data
• Excellent communication, leadership, and stakeholder management skills
• Ability to manage multiple studies, risks, and timelines

Education

• Bachelor’s in Clinical/Life Sciences, Nursing, Allied Health, or related field
• OR Master’s in Science