Central Monitor Manager
Amgen · Hyderabad · onsite · Posted 59d ago
Undisclosed8–13 yrsfulltimeSourced from
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About this role
Central Monitor What you will do
Lets do this. Lets change the world. In this vital role you will lead proactive, data-driven central monitoring across clinical programs, applying advanced analytics and structured review to detect early signals that may impact patient safety, data quality, and protocol adherence, and translating these into actionable insights that improve study execution.
- Lead proactive, data-driven risk surveillance across studies using central monitoring analytics to detect trends, anomalies, and emerging risks
- Translate complex statistical and operational findings into clear, actionable insights, recommending targeted interventions to study teams, CRAs, and functional leads
- Partner closely with Data Delivery Leads to implement, monitor, and continuously refine RBQM strategies (e.g., QTLs, KRIs, SRAs) across the study lifecycle
- Act as a subject matter expert in central monitoring tools and methodologies, driving consistent use and elevating team capability in signal detection and interpretation
- Document signal detection outputs, rationale, and recommended actions in an inspection-ready manner aligned with regulatory and internal governance expectations
- Facilitate feedback loops across sites, CRAs, and study teams to ensure issues are resolved and drive continuous process and quality improvement across the portfolio
We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.
Basic Qualifications: - Doctorate/Masters degree with 8-15 years of clinical execution experience
- Minimum 8 years of work experience in life sciences or medically related field and managing data on biopharmaceutical clinical research experience.
- Experience with Risk-Based Monitoring (RBM) tools such as CluePoints is highly preferred.
- Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
- Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management
- Experience in analyzing broad clinical trial data sets for trends
Sourced from naukri
Skills
data qualityBIOTECHclinical researchclinical trialssubject matter expertquality improvementAnalyticsMonitoring ToolsoncologyResearchLife SciencesSite Managementquality management
About Amgen
Amgen
Biotechnology
1.5k+
employees
1980
46 years old
Hyderabad, Telangana
India
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Amgen operates in the biotechnology sector, developing and delivering advanced medicines to address critical health challenges globally.
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