Job Description
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...