What the Risk and Central Monitoring Manager does at Worldwide Clinical Trials

This role coordinates cross-functional risk management and central monitoring activities for assigned clinical trials in accordance with International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines. The role supports study teams by prioritizing quality across the study and ensuring consistency within programs, therapeutic areas, and/or sponsors.

What you will do

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

• Understands the study budget and protocol content for assigned trials

• Oversees all Risk-Based Quality Management activities on assigned studies

• Supports the development of the Project Management Plan for the assigned program or study and may provide advice on the development of other functional plans

• Develops the Central Monitoring Plan for the assigned study and gains Global Project Lead (GPL) and sponsor approval

• Delivers training to study teams regarding the RBQM strategy, including study risk assessment, centralized monitoring, Key Risk Indicators (KRIs), 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 or trial

• Drafts and finalizes the initial risk assessment, ensuring cross-functional involvement

• Facilitates the identification of KRIs and/or QTLs as part of the study monitoring strategy, when applicable

• Oversees the setup of the central monitoring dashboard and central monitoring reviews performed throughout the study, when applicable

• Supports the GPL in ensuring compliance with cross-functional review of risks throughout the trial

• Performs central monitoring activities, when applicable, including review of study- and site-level KRIs and study-level QTLs, review of system outputs, identification of outliers, trends, or signals, and proposal of actions for assessment by the study team

• Follows up with study teams as appropriate for action or issue resolution

• Completes User Acceptance Testing (UAT) of RBQM technology, when applicable

• Maintains the Risk Library

• Ensures inspection readiness for risk assessment and centralized monitoring scope

• Ensures adherence to the budget and escalates issues appropriately when needed

• Participates as required in bid defense meetings, sponsor meetings, audits, and other third-party meetings

• Presents at Risk Manager Forum meetings

• Supports the development of departmental strategies and processes

• Acts as a mentor for new or 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.

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

• Strong analytical skills to analyze complex data and provide insight into risk reports, trends, and data outliers

• 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, including proficiency in Microsoft Office

Your experience

• Bachelor of Science (BSc), Registered Nurse (RN), or an equivalent combination of knowledge, skills, and experience

• At least five years of experience in clinical research and at least three years of experience and knowledge in risk-based monitoring and associated International Council for Harmonisation and regulatory guidance

• Prior experience in central monitoring and as a Risk Manager

• Demonstrated critical-thinking ability to determine root causes and appropriate solutions when identifying issues

• Demonstrated ability to lead and align teams to achieve project milestones, with the capability to work effectively in a global environment

• 10% international travel required

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

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.