Senior Central Monitor

At ICON Strategic Solutions, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

That's our vision. We're driven by it. And we need talented people who share it.

If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

As Senior Central Monitor, you will collaborate with the Central Statistical Monitor and Clinical Study Team to understand the study data and risk reports to monitor data quality, patient safety and relevant risks, you will be 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.
Within the Clinical Operations Excellence Organization, you will will play a vital role in the Risk-Based Quality Management process and is a key driver to facilitate the RBM process as a subject matter expert and change champion.

What you will be doing:

• Review protocols and study related documentation and along with clinical study team, assess critical data and critical processes, mitigation strategies and monitoring controls.
• Define Key Risk Indicators (KRIs), Data Quality Assessment (DQA), Quality Tolerance Limits (QTL) required for each study and ensure the proper set up in RBQM system while ensuring consistency across studies and programs.
• Uses PowerBI, CluePoints and TRI TRIAL OPRA Platforms as applicable to navigate dashboards and analyze data.
• Access EDC/RAVE, Vendor systems, CTMS, to further investigate risk signals.
• Maintain and review RBQM tools, plans and risk workbooks during the lifecycle of a study.
• Ensure proper TMF filling to meet inspection readiness requirements.
• Manage the RBQM implementation process, organize required meetings with the stakeholders and follow up with the teams to meet deliverable timelines.
• Develops and reviews Risk-Based Quality Management related plans.
• Ensure analytics platform is properly set-up, timely reviewed and process is standardized across studies.
• Provide technical oversight, guidance and coordination for all the centralized monitor activities.
• Participate in RBQM team meetings and collaborates in the department initiatives.
• Perform centralized monitoring activities including review of system outputs.
• Work with Central Statistical Monitors, Global Clinical Study Managers, Medical Monitors, Biostatisticians and Data Managers to ensure all risk signals are evaluated and properly mitigated.
• Work with the study team to define actions required to address risk signals and findings and follow up until action resolution.
• Ensure timely review of risks and update RBQM tools and systems as required during the course of a trial.
• Develop, implement, and maintain Quality Control related documentation for RBQM related activities to ensure data completeness and accuracy.
• Ensure RBQM system and processes are aligned with ICH GCP standards, Corporate SOPs and regulatory requirements.
• Develop, implement, and maintain Quality Control related documentation for RBQM related activities to ensure data completeness and accuracy.
• 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.

You have:

• Bachelor's Degree or above qualification in a life sciences discipline
• Strong understanding of ICH E6 (R2), ICH E6 (R3) draft and regulatory guidelines, particularly in relation to risk-based monitoring (RBM or RBQM)
• 3+ years' professional experience in the clinical research industry (Site Monitoring, Quality Assurance, Project Management, Data Management).
• Relevant pharmaceutical industry experience
• Strong knowledge of clinical research related processes
• Clinical trials Risk Assessment and Mitigation knowledge
• Experience in risk management and development of risk tools
• Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data
• Experience with or ability to learn data visualization techniques.
• Proficient experience using commercial clinical data management systems and/or EDC products, CTMS, Vendor Systems (IWRS, Central Lab, Imaging).
• Therapeutic Area knowledge, especially ONCOLOGY
• Working knowledge of clinical data and relevant data standards
•  Awareness of relevant data standards, e.g., CDISC, CDASH, SDTM

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.

#LI-Remote

#LI-NS1