Senior Manager - Adaptive Monitoring Excellence
- United States
- Project Management
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
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 on our mission to shape the future of clinical development.
What you will be doing:
- As assigned to support study execution teams, responsible for the implementation of Adaptive Monitoring procedures
- Interprets critical data, critical processes, and key risks assigned for site monitoring mitigations to determine study specific site monitoring requirements
- Leads adaptive monitoring strategy meetings, engaging cross-functional study team members to identify study-level SDV and SDR strategies, aligned with adaptive monitoring schemas
- Ensures risk-based monitoring strategies are integrated and site monitoring functional plans, and ensures strategies are correctly configured in technology solutions (TSDV, Veeva CDMS, CTMS etc)
- Partners with RBQM Operations team to ensure central monitoring findings and other signals identified for site monitoring mitigation are effectively communicated and addressed by site monitoring teams, documenting any need for the adjustment of source data verification or source data review targets
- Performs periodic assessment of the compliance with monitoring plans at the study, region, site, monitoring partner and personnel levels, and identifies and escalates issues and emerging monitoring compliance risks to the study execution team
- Leverages identified signals to coordinate Monitoring Oversight Visit activities for selected studies, and ensures appropriate processing of related visit reports and findings
- Maintains up-to-date, accurate documentation of Adaptive Monitoring activities
- Maintains high quality, consistency, and compliance with RBQM procedures across studies
- Recommends adaptive monitoring process adjustments based on feedback and data-driven trends in overall RBQM success measures
- Identifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with CQM’s RBQM processes
- Acts as a change agent, champion, subject matter expert and point of contact for adaptive monitoring concepts, leading study teams to understand and follow the best practices to achieve maximum benefit
- Supports and participates in internal and external audits and inspections as related to adoption of RBQM and Adaptive Monitoring
You are:
- Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
- Minimum of 6 years of experience in the pharmaceutical or CRO industry
- Minimum of 2 years of experience in Risk Based Quality Management, Risk-Based Monitoring, or Adaptive Monitoring roles
- Robust understanding of the drug development process and clinical trial execution
- Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP)
- Experience in site monitoring and risk-based monitoring, including onsite and remote monitoring models
- Experience in establishing risk-appropriate monitoring approaches, and assessing site monitoring compliance and quality/effectiveness
- Knowledge of RBQM IT systems, targeted SDV/SDR tracking, and EDC systems
- Demonstrated ability to effectively lead cross functional team meetings
- Experience forming cross-functional collaborations; strong interpersonal skills
- Supports a culture of continual improvement and innovation; promotes knowledge sharing
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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 or submit a request here.
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
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
Teaser label
Career ProgressionContent type
BlogsPublish date
05/30/2023
Summary
Clinical research is the backbone of the life sciences industry. In fact, the established processes used to accurately trial and research medical, surgical and behavioural intervention are ess
Who we are
Similar jobs at ICON
Salary
Location
United States, Canada
Department
Project Management Roles
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project Management
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
2024-110310
Expiry date
01/01/0001
Salary
Location
US, Portland, OR
Department
Full Service - Development & Commercialisation Solutions
Location
Portland
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Project Management
Job Type
Permanent
Description
At ICON, 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. Our ‘Own I
Reference
JR117438
Expiry date
01/01/0001
Author
Frank LampartAuthor
Frank LampartSalary
Location
United States
Department
Project Management Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project Management
Job Type
Permanent
Description
As a Sr Project and Portfolio Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110256
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States, Canada
Department
Project Management Roles
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project Management
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
2024-110255
Expiry date
01/01/0001
Salary
Location
London, France, Spain
Department
Project Management Roles
Location
France
Spain
London
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project Management
Job Type
Permanent
Description
As a Global Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110235
Expiry date
01/01/0001
Author
Tanzina GuerniAuthor
Tanzina GuerniSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Development & Commercialisation Solutions
Location
Blue Bell
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Project Management
Job Type
Permanent
Description
At ICON, 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. Our ‘Own
Reference
JR116643
Expiry date
01/01/0001
Author
Frank LampartAuthor
Frank Lampart