Manager, Clinical Risk and Analytics
UK Visa Sponsorship Analytics
Analytics are greyed out due to low classification confidence (50.0%).
Occupation Type
Business and financial project management professionals
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£56,500
(£28.97 per hour)
Occupation rate applies
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Description
Manager, Clinical Risk & Analytics (CR&A)
Overview
The Manager, Clinical Risk & Analytics (CR&A) reports into the CR&A function and is responsible for cross-functional risk management and central monitoring activities for their assigned clinical trials in accordance with ICH GCP E6 requirements.
Summary Of Key Responsibilities
The Clinical Risk & Analytics (CR&A) manager will.
Overview
The Manager, Clinical Risk & Analytics (CR&A) reports into the CR&A function and is responsible for cross-functional risk management and central monitoring activities for their assigned clinical trials in accordance with ICH GCP E6 requirements.
Summary Of Key Responsibilities
The Clinical Risk & Analytics (CR&A) manager will.
- Lead study teams in the identification and management of Critical to Quality’ (CtQs) factors, safety, and data integrity risks, operational and other protocol execution risks at study start and throughout study.
- Lead the development of the Risk Management and Action Plan (Risk MAP), RBQM Plan, Integrated Data Quality Plan (IDQP), and Targeted SDV and SDR planning on assigned trials.
- Lead definition and selection of Key Risk Indicators (KRIs), and Quality Tolerance Limit (QTL) parameters and other applicable assessments and visualizations for their assigned trials.
- Lead delivery of timely and high-quality RBQM system analytic summaries reports and communicate findings to the cross-functional study team and CRO.
- Proven experience in a clinical research environment.
- College degree, preferably in a scientific, analytical, or technical discipline
- Minimum of 5 years’ experience in the pharmaceutical or CRO industry
- Working knowledge of clinical development processes, understanding concepts and principles of study design, conduct and close out, as well as clinical program develop.
- Knowledge of Good Clinical Practice/ICH E6 (R2+), ICH E8 R1 Guidelines and/or other applicable regulatory requirements.
- Experience and understanding of Risk Based Monitoring and Site Profiling Tools preferred.
- Familiarity and good understanding and knowledge of clinical trials risk management concepts and principles in the Pharma or CRO industry
- Good understanding and knowledge of risk management concepts and principles
- High degree of accuracy and attention to detail
- Strong critical thinking and analytical skills, and Aptitude for data analytics, mathematical and statistical concepts is a plus.