PRAHS Sr Central Monitor in United States
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.
Working as a Senior Central Monitor outsourced to a single pharmaceutical company you will be providing services which include working within the Risk Management-Central Monitoring Group and leads clinical study teams in the study-specific design and implementation of Analytical Risk-Based Monitoring (ARBM) on clinical trials (Ph I-IV).
The Senior Central Monitor is responsible for a range of tasks that spans the areas of risk identification & mitigation, data analysis, leading cross-functional teams, communicating with study team members on multiple levels, providing ongoing training on ARBM-related processes to teams, and participating in departmental initiatives related to innovation and process
- Services rendered will adhere to dedicated sponsor SOPs, WIs, policies, local regulatory
• Lead central study teams (including trial managers, data managers, study physicians, study scientists,
quality colleagues, and statisticians) in the identification of critical study data/processes and in
related potential risks.
• Coordinate trial team translation of identified risks and critical data/processes into risk mitigation
and oversight plans to be followed during study execution.
• Lead the central study team in making appropriate decisions regarding site management,
data review, and contingency plans and provide their own input into related study plans.
• Coordinate with the cross-functional central study team to ensure compliance with the risk oversight
plan established during ARBM design and to oversee site risk parameters.
• Responsible for ongoing study and operational data reviews, as well as associated follow-up to
resolution of their findings in conjunction with appropriate central and field team members. This is
to be accomplished through the utilization of multiple internal systems, internal/external databases,
custom report creation, and the use of a selection of data analysis and visualization tools, followed
by the proper interpretation and investigation of risk indicators and trends.
• Successfully lead recurring cross-functional study team meetings inn a virtual environment.
Organize, lead, document meetings, communicate effectively, and guide and influence colleagues in
new methodologies is critical.
• Ensure Inspection readiness for sites by maintaining complete, accurate and timely data and essential
documents in systems utilized for trial management (e.g. CTMS and eTMF) according to expectations
(metrics) and archiving retention requirements, including storage in a secure area.
• Complying with relevant training requirements and developing therapeutic knowledge sufficient for
role and responsibilities to ensure inspection readiness.
• Full utilization by timely and accurate time reporting.
Minimum 4 years clinical trial support or pharmaceutical industry experience
Read, write, and speak fluent English; fluent in host country language
Knowledge of ICH-GCP and local regulatory requirements
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse)
Prior experience using Clinical Data Management Systems
Basic knowledge of medical terminology
On site monitoring experience preferred
As a Senior Central Monitor you won’t be required to travel so this position could suit a CRA who no longer wishes to travel. Or a Clincal Data Coordinator / Data Manager looking for a change in direction. You can be home or office-based so this flexibility could enhance your work/life balance.
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.
External Company Name: Pharmaceutical Research Associates, Inc
External Company URL: http://prahs.com/
Post End Date: 10/16/2021