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 3,500+ 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 Risk Managers Do At Worldwide

Will coordinate cross-functional risk management and central monitoring activities for assigned clinical trials in accordance with monitoring in accordance with ICH GCP E6 requirements. Will assist in the maintenance of the risk library and provide guidance to ensure consistency within programs, therapeutic areas and/or sponsors

What You Will Do

• Drafts initial risk assessment and supports the project team in finalizing 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 centralized 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.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.