The SDTL / Central Monitoring Manager works within the Risk Management – Central Monitoring Group and leads clinical study teams in the study‑specific design and implementation of Analytical Risk‑Based Monitoring (ARBM) for clinical trials (Phase I–IV).

Responsibilities

• Risk identification and mitigation
• Data analysis and interpretation
• Leading cross‑functional teams
• Multi‑level communication with study team members
• Ongoing training on ARBM‑related processes
• Participation in innovation and process improvement initiatives

Deliverables

GRAD (Level 0) / BASE (Level 1)

Services Rendered

• Adhere to applicable Sponsor SOPs, work instructions, policies, and local regulatory requirements.
• Support central study teams (including trial managers, data managers, study physicians, study scientists, quality colleagues, and statisticians) in identifying critical st...