Job Information
ICON Strategic Solutions Senior Central Monitor in Helena, Montana
As a Sr. Central Monitor you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
RESPONSIBILITIES
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
QUALIFICATION
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
Why 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.
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.
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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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