Clinical Data Risk Analyst
- Sofia, Warsaw, Johannesburg
- Clinical Data Management
- ICON Full Service & Corporate Support
- Hybrid: Office/Remote
About the role
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.
Clinical Data Risk Analyst - EMEA based (Office or Remote working).
The Role:
We are looking for a Clinical Data Risk Analyst to join the Clinical Risk Management team at ICON. Candidates for this exciting opportunity should have strong knowledge of Clinical Research, Risk Based Quality Management, and Central Monitoring in the Pharma or CRO industry.
As functional lead of Clinical Risk Management, the Clinical Data Risk Analyst is responsible for set-up and implementation of Central Monitoring on a portfolio of clinical studies.
The Role:
Recognize, exemplify and adhere to ICON's values, which center on Collaboration, Agility, Integrity and Inclusion
Recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Creation and ownership of the Central Monitoring Plan
Provide input to study risk assessment and propose appropriate and tailored risk indicators for central analysis, in line with holistic data monitoring model.
Support set-up and testing of data analysis platform
Review clinical study data and make independent decisions to identify potential site performance and site organization issues.
Manage operational risk log for Clinical Risk Management activities.
Train and support the project teams about interpretation of Central Monitoring Signals and relevant decision making for study conduct.
Support preparation, conduct and follow-up of the Quality Risk Review Meetings for effective communication with the cross functional project team to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issues.
Oversee Clinical Risk Management project budget, scope of work, forecasting.
Communicate effectively with the project team: CRAs, Project Managers, Clinical Trial Managers, DM Staff, Medical staff, Scientific Council to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issue.
Support cross functional and external Data Analysis Platform users with system use.
Act as mentor for Central Monitoring team members.
Travel (approximately 5%) domestic and/or international.
Other duties as assigned.
To be successful in the role, you will ideally have:
University/Bachelor’s Degree in medicine, science or equivalent degree/experience
Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management and Central Monitoring
3-4 years’ experience in Clinical Research (CRA or DM background), or relevant skillset
Knowledge of database technologies and processes
Fluent in written and spoken English.
Excellent communication and interpersonal skills, attention to detail
Demonstrate ownership and accountability for achieving results.
Ability to work within a team environment and manage competing priorities in a changeable environment.
Proven Functional Lead skills and the ability to work independently and apply critical thinking skills to resolve study related issues.
Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license and passport.
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
Our PeopleContent type
BlogsPublish date
10/02/2023
Summary
An Evolution of Progress and Success: Zashan's story a Clinical Research Associate (CRA) Having a satisfying career involves finding a company that prioritizes progress, improvement, and chances f
Teaser label
Our PeopleContent type
BlogsPublish date
08/22/2023
Summary
Skip to SAS Programming jobs What is SAS Programming? A statistical software suite called SAS for data management was established by the SAS Institute between 1966 and 1976 for the purposes
Who we are
Similar jobs at ICON
Salary
Location
India, Chennai
Location
Chennai
Trivandrum
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Data Management
Job Type
Permanent
Description
Functional Knowledge: •Working knowledge of clinical data science activities (Data review, risk management & analytics, clinical systems). •Working knowledge of project management, including the predi
Reference
JR120927
Expiry date
01/01/0001
Author
Ekta Chandra SrivastavaAuthor
Ekta Chandra SrivastavaSalary
Location
India, Trivandrum
Location
Chennai
Trivandrum
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Data 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
JR120251
Expiry date
01/01/0001
Author
Ekta Chandra SrivastavaAuthor
Ekta Chandra SrivastavaSalary
Location
India
Department
Biometrics Roles
Location
India
Business Area
ICON Strategic Solutions
Job Categories
Biometrics Portfolio
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
2024-111021
Expiry date
01/01/0001
Author
Kalpana KulasekaranAuthor
Kalpana KulasekaranSalary
Location
US, Lenexa KCI (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Lenexa
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Data Management
Job Type
Temporary Employee
Description
CDQA – Lenexa, KS:ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharm
Reference
JR121574
Expiry date
01/01/0001
Author
Kahla CuretonAuthor
Kahla CuretonSalary
Location
Bulgaria, Sofia
Location
Sofia
Warsaw
Bucharest
Johannesburg
Bratislava
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Data Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organzation. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us o
Reference
JR121119
Expiry date
01/01/0001
Salary
Location
Bulgaria, Sofia
Location
Sofia
Warsaw
Bucharest
Johannesburg
Bratislava
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Data 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 o
Reference
JR120928
Expiry date
01/01/0001