Risk Manager - Australia - Remote Apply remote type Remote locations Virtual Australia time type Full time posted on Posted Today job requisition id JR100385
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 3,500+ 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.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What you will do
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. Independently provides subject matter expertise for the development and maintenance of the monitoring strategy required for the trial. Supports the GPL in ensuring compliance with cross-functional review of risks throughout the trial. Leads the identification of Key Risk Indicators (KRIs) during the set-up of studies. Collaborates with study team and sponsor to identify and track trial level Quality Tolerance Limits. Ensures Inspection Readiness for risk assessment and centralised monitoring scope. Maintains the Risk Library. Participates as required in Bid Defense Meetings, sponsor meetings and audits or other third-party meetings. What you will bring to the role
Excellent communication, presentation and interpersonal skills. Excellent planning and organizational skills with effective time management. Good 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 mitigate potential threats to the successful conduct of a clinical research project. Ability to mentor. Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities. Your experience
BSc/RN or equivalent combination of knowledge, skills and experience. At least 5 years' experience in clinical research and at least 2 years' experience and knowledge of Risk Based Monitoring and associated ICH/Regulatory guidance required. We love knowing that someone is going to have a better life because of the work we do.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.
About Us This is who we are.
We're a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever.
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