ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Sr. Central Monitor would be collaborating with the Central Statistical Monitor and Clinical Study Team to understand the study data and risk reports using sponsor available technology to monitor data quality, patient safety and relevant risks, he/she would be the first person to draft any study related risk/issue(s) and maintain the Risk Management Plan and tools. This role will be involved early in the protocol development process to support risk identification, risk assessment, finalizing quality thresholds/triggers and risk action planning as well. This will be in close collaboration and ongoing discussion with the clinical study team.
Primary Responsibilities
• Centrally reviews clinical data at aggregate level, using analytic reporting tool(s) to support the identification of risks and data patterns/trends.
• Reviews clinical and external data for subjects enrolled in clinical research protocols based on functional plans.
• Mitigates risks by using signal detection and quality indicators.
• Communicates and triages issues to appropriate roles for follow-up and action to address root cause.
• Creates analytic outputs and presentations to facilitate data reviews and to support data-driven decision-making.
• Supports activities related to development of the Clinical Data Management Systems (CDMS).
• Contributes to the development and maintenance of study documents specifying central monitoring strategy, approach and procedures on assigned protocols/projects.
• Provides input to applications, databases and systems used to monitor study data.
• Leads or supports the clinical data review activities associated with a clinical trial and the delivery of data fit for analysis
• Collaborate with CTOM/COM/Regional COMs and on-site monitors to ensure they are well equipped with the details of site related risk/issue(s) to plan timely site intervention (site visits or telephonic contacts with sites) and to ensure more efficient and focused activities during monitoring visits.
Activities typically include developing the Risk-Based Quality Management and Risk-Base Monitoring using PowerBI, CluePoints and TRI TRIAL OPRA Platforms for applicable studies, ensuring key risk indicators (KRIs) and data quality assessment (DQA) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, and follow up for the issue resolution
- Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized
- Provide technical oversight, guidance and coordination for all the central monitor activities
- Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level
- Ensure RBM system alignment with the protocol and adherence to ICH GCP, SOPs, corporate standards and regulatory requirements
- Work with Study Team to define the issue resolution for the review of findings as signals and actions
- Develop, implement, and maintain Quality Control related documentation for RBM related activities to ensure data completeness and accuracy
- Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions
- Work with Central Statistical Monitor and GCOMs to ensure all signals and actions are properly mitigated and RBM systems properly released
- Ensure lessons learnt during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning
- Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables
- Comprehensive experience in clinical monitoring, clinical data analytics and/ or data management activities.
- Ability to work independently to drive RBQM activities as a change champion, keeping the teams on track to risk management and oversight activities.
- Excellent communication and coordination skills strongly preferred with experience working and communicating within cross-functional teams.
- Knowledge of overall clinical trial management process, understanding of the protocol, study associated risks and their significance in monitoring the clinical study.
- Critical thinking and analytical skills to understand/ analyze complex data and provide insight into risk reports, trends, and outliers in data.
- Therapeutic area specific experience and knowledge – Oncology/Hematology preferred.
- Technical ability to use the relevant technology and risk-based tools/platforms effectively.
- Bachelor's Degree in a scientific or business related discipline
- 3+ years' professional experience, ideally in data management/programming or other technical area
- Demonstrated knowledge of clinical development including knowledge and understanding of the principles of GCP, particularly in relation to risk-based monitoring
- Awareness of relevant data standards, e.g., CDISC, CDASH, SDTM
- Ability to critically analyze, interpret, and summarize statistical output from risk-based quality management software, e.g., CluePoints
- Ability to manage tasks, time and priorities
- Demonstrated effective verbal and written communication skills, including the ability to communicate in a remote team environment and adapt communications to audience
- Relevant pharmaceutical industry experience
- Experience with or ability to learn data visualization techniques, e.g
- Proficient experience using commercial clinical data management systems and/or EDC products
- Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data
- Good understanding of ICH and regulatory guidelines
- Working knowledge of clinical data and relevant data standards
- Strong written and oral communication skills, and project management skills
- Proven ability to operate with limited oversight
- Knowledge of at least 1 Therapeutic Area especially ONCOLOGY
- Proven ability to manage delivery under tight timelines
Bachelor’s degree in quantitative, scientific or health-related field
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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