Risk and Central Monitoring Manager - US - Remote -

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 the Risk and Central Monitoring Manager does at Worldwide

Will coordinate cross-functional risk management and central monitoring activities for assigned clinical trials in accordance with ICH GCP guidelines.  Will help focus teams on prioritizing quality on the study and provide support to ensure consistency within programs, therapeutic areas and/or sponsors.

What you will do

• Supports with Risk-Based Quality Management (RBQM) activities within the assigned project team:

• Oversees all Risk-Based Quality Management activities on their assigned study

• Supports the development of the Project Management Plan for the assigned program/study. May provide advice on the development of other functional plans.

• Develops the Central Monitoring Plan for the assigned study and gains GPL and Sponsor approval.

• Delivers training to study teams in regard to the RBQM strategy, which may include study risk assessment, centralized monitoring (Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs)), and the overarching monitoring strategy

• Independently provides subject matter expertise for the development and maintenance of the study-level monitoring strategy required for the program/trial.

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 trial financial concepts

• Analytical skills to understand/ analyze complex data and provide insight into risk reports, trends, and outliers in data

• Ability to apply problem-solving and critical thinking techniques to resolve complex issues and apply a risk-based approach to identify and mitigate potential threats to the successful conduct of a clinical trial

• Ability to mentor

Your experience

• BSc/RN or equivalent combination of knowledge, skills, and experience

• At least 5 years' experience in clinical research and at least 3 years' experience and knowledge of Risk-Based Monitoring and associated ICH/Regulatory guidance required

• Prior experience in Central Monitor/ within Central monitoring, and as a Risk Manager is required

• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues

• Demonstrated ability to lead and align teams in the achievement of project milestones, as well as demonstrated capability of working in a global environment

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.