Principal Risk Based Study Manager/Monitor
- United States
- Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
- ICON Strategic Solutions
About the role
This vacancy has now expired. Please click here to view live vacancies.
As a Risk Based Study Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
The Risk-based Study Management Principal role is responsible for timely and high-quality Risk-based Study Management (RBSM) strategy supporting the Vertex portfolio. This management-level RBSM Lead role is responsible for supporting the study-specific risk assessment process prior to leading the study teams through the periodic risk review process which includes ongoing assessment of Key Risk Indicators (KRIs) to identify issues and emerging risks in clinical trial variables (trends/outliers/poor performing sites) through the review of aggregate data. The RBSM Lead demonstrates an exceptional degree of technical and clinical trial expertise while working directly with the cross-functional study team to support the quality oversight of sites, countries, and studies both within the RBSM platforms via the study-specific analytics as well as the parallel process activities.
- Facilitates the initial risk assessment activities including documenting the study-specific RBSM strategy
- Facilitates review of periodic risk review output with the Study Team and provides recommendations and guidance on actions
- Advises the study team on any updates to the monitoring strategy during the study conduct based on the output from the monthly review activities
- Oversees the risk review processes for assigned studies
- Contributes to the development of standards including tools/templates for RBSM activities (can function as a workstream owner)
- Ensures the training of RBSM Central Risk Managers (at all levels) and Study Team members on processes, platforms, tools, and templates
- Provides technical expertise to set-up and test study-level Risk Assessment Module and Central Monitoring Modules design in the designated RBSM platform
- Provides input on initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines, and deliverables
- Contributes to periodic portfolio level risk review with functional area representatives to identify enterprise-level trends, corrective actions, etc.
- Able to resolve conflicts, influence and communicate cross-functionally with key stakeholders and customers.
- Functional/line management of RBSM Central Risk Managers (at all levels)
- Performs other duties as assigned
You are:
Required Education Level |
· Bachelor’s degree in relevant discipline (or equivalent degree)
|
Required Experience |
· Prefer minimum of 5+ years of relevant work experience in the Biotech or Pharmaceutical industry, or equivalent comparable background · Prefer minimum of 1-2 years’ experience working in centralized monitoring and/or risk-based study management
|
Required Knowledge/Skills |
· Technical expertise and business experience in supporting clinical trial database development, data management, site monitoring, etc. · Thorough understanding of the processes associated with clinical study management and data management · Project management skills and technical capabilities · Works independently, receives instruction primarily on unusual situations · Ability to organize tasks, time, and priorities; ability to multi-task · Effective and appropriate verbal and written communication with internal and external stakeholders, locally and globally · Must have experience with data visualization and data analytics tools · Previous experience with the risk assessment process optional |
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.jpg)
Teaser label
Inside ICONContent type
BlogsPublish date
01/17/2025
Summary
Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are
.jpg)
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label
Career ProgressionContent type
BlogsPublish date
07/20/2023
Summary
Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic
Similar jobs at ICON
Salary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2025-121985
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Boston
Department
Biometrics Roles
Location
Boston
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a Clinical Data Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-121467
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Saint Paul
Department
Biometrics Roles
Location
Saint Paul
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a Clinical Data Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-121466
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Saint Paul
Department
Biometrics Roles
Location
Saint Paul
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a Rave Database Developer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-121392
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Worcester
Department
Biometrics Roles
Location
Worcester
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a Rave Database Developer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-121393
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
United Kingdom, Warsaw, Brussels
Department
Biometrics Roles
Location
UK
Brussels
Warsaw
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a Data Management Reviewer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This is an hybrid role and it requires 3
Reference
2025-121463
Expiry date
01/01/0001
Author
Niki ScottoAuthor
Niki Scotto