Associate Risk Manager ~US/Canada/LATAM
Multiple Locations: Canada • Brazil • United States • Mexico
Requisition Number: 5005
Position Title: Risk Manager
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Associate Risk Manager
The Associate Risk Manager will support co-ordination of cross-functional risk management and central monitoring activities for assigned clinical trials in accordance with ICH GCP E6 requirements. Will assist in the maintenance of the risk library and provide support to ensure consistency within programs, therapeutic areas and/or sponsors.
Some team members may focus on a limited number of these responsibilities depending on requirements. Tasks may include but are not limited to:
Supports with Risk Management activities within the assigned project team:
- Understands the study budget and protocol content for their assigned trial.
• Is able to support with the development and maintenance of the monitoring strategy required for the trial.
• As required, support to train the study team regarding the risk assessment and centralized monitoring.
• Drafts initial risk assessment and supports the project team in finalising the Risk Planning Tool, ensuring cross functional involvement.
• Develops the RMP for the assigned study and gains GPL and Sponsor approval. May provide advice on the development of other functional plans.
• Supports the GPL in ensuring compliance with cross-functional review of risks throughout the trial.
• Ensures Inspection Readiness for risk assessment and centralized monitoring scope.
• Maintains the Risk Library.
• When required, will conduct study level review of KRIs/KPIs or statistical monitoring.
• May be required to perform central monitoring activities including review of system outputs, identification of outliers, trends or signals and propose actions for assessment by study team. Follow-up with study teams as appropriate for action or issue resolution
• Conducts and documents study/site level review of Key Risk Indications/Key Performance Indicators and where required, statistical monitoring and tracking of study Quality Tolerance Limits
• To participate as required in sponsor meetings and audits or other third-party meetings.
OTHER SKILLS AND ABILITIES:
- Excellent communication, presentation and interpersonal skills.
• Excellent planning and organizational skills with effective time management
• Excellent interpersonal skills
• Knowledge of clinical project financial principles
• Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identify and mitigating potential threats to the successful conduct a clinical research project.
• Ability to lead and motivate assigned team (if applicable)
• Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
• Proficiency in Microsoft Office
- BSc/RN or equivalent combination of knowledge, skills and experience
• At least 4 years knowledge of Risk Based Monitoring and associated ICH/Regulatory guidance required. Experience as a Central Monitor preferred.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
• Ability to work cross-functionally in the achievement of project milestones, as well as demonstrated capability of working in global environment
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Employment Type: Regular
Community / Marketing Title: Associate Risk Manager ~US/Canada/LATAM
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.