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).
ResponsibilitiesRisk identification and mitigationData analysis and interpretationLeading cross‐functional teamsMulti‐level communication with study team membersOngoing training on ARBM‐related processesParticipation in innovation and process improvement initiativesDeliverablesGRAD (Level 0) / BASE (Level 1)Services RenderedAdhere 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 study data, processes, and associated risks.Coordinate translation of identified risks and critical data/processes into risk mitigation and oversi...