Risk and Central Monitoring 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!

SUMMARY:  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.
 

RESPONSIBILITIES:

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 Based Quality Management (RBQM) activities within the assigned project team:
 

• Understands the study budget and protocol content for their assigned trial.
• 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, centralised 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.
• Drafts and finalizes the initial risk assessment ensuring cross functional involvement.  
• As part of the initial risk assessment and when applicable, facilitates the identification of KRIs and/or QTLs as part of the study monitoring strategy.
• Where applicable, oversees the set-up of the central monitoring dashboard and the central monitoring reviews performed throughout the study.
• Supports the GPL in ensuring compliance with cross-functional review of risks throughout the trial.
• When applicable, performs central monitoring activities including but not limited to, review of study/site level review of KRIs and study level QTLs, review of system outputs, identification of outliers, trends or signals and propose actions for assessment by study team. Follows-up with study teams as appropriate for action or issue resolution.
• When applicable, completes User Acceptance Testing (UAT) of RBQM technology
• Maintains the Risk Library.
• Ensures Inspection Readiness for risk assessment and centralised monitoring scope.
• Ensures adherence to budget and escalates appropriately where needed.
• Participates as required in Bid Defense Meetings, sponsor meetings and audits or other third-party meetings.
• Presents at Risk Manager Forum meetings.
• Supports the development of department strategies and processes.
• Acts as a mentor for new/junior team members.

Performs other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
 

OTHER SKILLS AND ABILITIES:

• 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/ analyse 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
• Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
• Computer literate and numerate with a willingness to adapt to various computer systems. Proficiency in Microsoft Office 

REQUIREMENTS:

• 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 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 global environment

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

The company reserves the right to amend this job description in consultation with the employee to reflect changes in its organisational structure or to the job itself in line with emerging business needs

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.