Top 3 Must Have Skill Sets:
Any degree with Trial Risk Management Experience
Risk Based Clinical Execution work experience
Advanced knowledge of clinical trial management and operations
With increased complexities of clinical development, risk management has become an essential and integral piece of clinical trial management, aligned with our Risk-Based Study Execution vision. At the core of risk management is the identification and ongoing assessment of potential risks through-out the lifecycle of a clinical trial.
Risk assessment is a systematic process for identifying and evaluating events that could affect the results of clinical study objectives. A robust risk assessment process in clinical trials forms the foundation for effective risk management. It requires a holistic approach to identify all potential risks, assess the probability of occurrence and impacts, and proactively perform root cause analysis to plan the right course of action.
Implementation of a robust risk assessment process is essential to empower a Clinical Study Team to better identify and evaluate the right risks for a clinical trial, all while maintaining the appropriate controls to ensure effective and efficient data quality, patient safety and regulatory compliance.
This role will be pivotal to the strategic and tactical development of risk management capabilities Specifically, the role will include:
• Contributing to the creation of a long-term strategy to develop a structured and coherent approach to risk management within clinical trials
• Identifying, assessing and managing risk
• Developing functional health and process adherence analytics
• Implementation and support of the growth of the Risk Global Library with input to developing the strategy for future long-term management of the Global Library
• Lead/participate in continuous improvement initiatives for the digital CT-RACT and the associated processes
• Collaborate with other Risk Management individuals to:
Support development of study team expertise in adoption of the digital CT-RACT
Schedule and support implementation hyper care sessions
• Stimulate meaningful and cross-functional collaboration / discussion within the Study / Program Teams to enable the creation of robust risk and mitigation plans
Skills and experience
• Sound understanding of the regulatory requirements for quality and risk management
• Experience across different phases of product development and therapeutic area
• Ability to articulate study risks in a clear and understandable way
• Advanced knowledge of clinical trial management and operations
• Ability to influence and change cultural behaviors;
• Communicate clearly and effectively
• Curiosity and passion for further development of Risk-Based Study Execution”
"This posting is for Contingent Worker, not an FTE"