Mgr Clinical Risk Management

Career Category

Clinical Development

Job Description

Clinical Risk Analyst

Role Name: Clinical Risk Analyst

Department Name: Global Development Operations

Role GCF: 5

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

The Clinical Risk Analyst is responsible for generating and translating study-level risk insights to enable proactive, data-driven decision-making across the conduct of clinical trials. This role is a key driver of Risk-Based Quality Management (RBQM), leveraging centralized monitoring, analytics, and cross-functional data sources to identify, assess, and mitigate risks to patient safety, data integrity, and study delivery.

Working closely with Study Delivery Teams, Central Monitors, and cross-functional stakeholders, the Clinical Risk Analyst leads structured risk review processes, ensuring that risks are identified early, understood in clinical and operational context, and addressed through clear, actionable mitigation strategies.

The role plays a critical part in connecting study-level risk signals to broader program and portfolio risk perspectives, maintaining a strong partnership with Associate Directors of Risk Management to ensure visibility, alignment, and aggregation of emerging trends. Through this, the Clinical Risk Analyst contributes to continuous improvement of risk models, monitoring approaches, and overall study execution quality.

Roles & Responsibilities:

• Lead centralized monitoring reviews using platforms such as CluePoints to drive risk identification, signal detection, trend analysis, and structured decision-making across assigned studies.
• Define, implement, and continuously refine Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), including thresholds, triggers, and escalation pathways aligned to study critical-to-quality factors.
• Provide expert input into Study Risk Assessments (SRA) during study start-up and contribute to the development of risk review strategies within the Integrated Data Review Plan (IDRP).
• Critically evaluate centralized monitoring outputs to distinguish true risk signals from noise, incorporating clinical and operational context to identify root causes and recommend appropriate mitigation actions.
• Integrate insights from Central Monitors and cross-functional data sources to develop a consolidated and continuously evolving view of study risk.
• Drive accountability for risk mitigation by ensuring actions are clearly defined, tracked, and followed through to resolution in collaboration with Study Delivery Managers and cross-functional stakeholders.
• Lead Root Cause Analysis (RCA) for significant or recurring risks and assess the effectiveness of mitigation actions to support corrective and preventive actions (CAPA).
• Own and communicate the evolving study risk narrative, including key trends, impacts, and mitigation effectiveness, to Study Delivery Teams, Functional Leadership, Process Owners, and Associate Directors of Risk Management.
• Establish strong alignment with Associate Directors of Risk Management to ensure study-level risk insights are visible, contextualized, and contribute to program and portfolio-level risk oversight and trend management.
• Support aggregation of study-level risk signals into broader risk perspectives by providing structured summaries, trend analyses, and escalation insights to enable effective program and portfolio risk management.
• Continuously optimize KRIs, QTLs, and monitoring approaches to improve predictive value, operational relevance, and overall RBQM effectiveness.
• Ensure accurate documentation and traceability of signals, decisions, and actions within the central monitoring platform and applicable systems (e.g., Signal and Action Tracker, TMF).
• Provide quality oversight of centralized monitoring outputs generated by Central Monitors, applying a sampling and QC approach to ensure consistency, accuracy, and robustness of analyses.

Basic Qualifications and Experience:

• Doctorate degree 1 year of clinical operations execution experience OR
• Master’s degree and 2 years of clinical operations execution experience OR
• Bachelor’s degree and 4 years of clinical operations execution experience OR
• Associate’s degree and 8 years of clinical operations execution experience OR
• High school diploma / GED and 10 years of clinical operations execution experience

Preferred Experience:

• 5 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience working in global clinical trial teams (phase 1-3 interventional trials) across multiple geographies
• Experience with risk-based site monitoring (onsite or remote/centralized)
• Experience with data-driven oversight in Risk Based Quality Management (RBQM) approaches
• Highly desirable is experience using the Cluepoints platform, preferably in a risk reviewer/risk co-ordinator role (reviewing signals and actions), or could be in a central monitor role (reviewing KRIs to create signals).

Functional Competencies:

Must-Have Competencies:

• Keen strategic thinking and problem-solving abilities, with a meticulous approach to managing data trends and risks.
• Outstanding verbal and written communication skills, with the ability to present complex information clearly and effectively.
• Excellent organizational and time management skills, with the capability to prioritize and deliver results independently
• Ability to recognize, highlight and resolve issues. 
• Demonstrates curiosity and willingness to take on new tasks.
• Expertise in clinical trial processes, clinical trial operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
• Assist in onboarding new team members by preparing training materials and access to systems.
• Experience with overseeing suppliers/contractors
• Cultural sensitivity and collaboration across global teams.
• Experience executing risk-based site monitoring, Corrective and Preventive Actions (CAPA) implementation, and risk mitigation to resolve operational challenges and ensure inspection readiness
• Understands importance of accuracy in documentation, data tracking, and compliance checks.
• Identifies discrepancies and escalates appropriately.
• Working knowledge of CTMS, eTMF, EDC
• Proficiency in Microsoft Office, strong analytical skills, and an aptitude for data analytics
• Ability to maintain accurate and timely data entry.
• Skilled in managing clinical trial data flow, documentation, and protocol adherence while ensuring regulatory compliance
• Open-mindedness towards skill development and active participation in internal training to build knowledge of clinical trial processes.
• Understanding of the clinical and pharmaceutical drug development process
• Knowledge of clinical regulatory requirements and guidelines for conducting clinical research and safety reporting (e.g., ICH-GCP)

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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