JUMP TO CONTENT

Clinical Data Risk Analyst

  1. Sofia, Warsaw, Johannesburg
JR117800
  1. Clinical Data Management
  2. ICON Full Service & Corporate Support
  3. Hybrid: Office/Remote

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.

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

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.

#LI-AH13

List #1

Day in the life

Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish 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

Ace your virtual job interview with these proven video interview tips.

Read more
A Journey of Growth and Excellence: An ICON Employee's Testimonial

Teaser label

Our People

Content type

Blogs

Publish 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

Zashan, who began his journey with us in 2016, has shared his experience and insights.

Read more
A picture of Mahesh
Why apply to be SAS Programmer with ICON?

Teaser label

Our People

Content type

Blogs

Publish 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

Teaser label

Mahesh Ganupooru talks about his time so far with ICON as SAS Lead.

Read more
View all

Who we are

Press play to find out more

Similar jobs at ICON

Clinical Data Coordinator

Salary

Location

Mexico, Mexico City

Department

Full Service - Early Clinical and Bioanalytical Solutions

Location

Mexico City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Data Management

Job Type

Permanent

Description

Clinical Data CoordinatorJR118138Site: Mexico 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 a

Reference

JR118138

Expiry date

01/01/0001

Fernanda Bezerra Read more Shortlist Save this role
Lab Data Analyst I

Salary

Location

US, New York, NY, Whitesboro

Department

Full Service - Laboratory

Full Service - Development & Commercialisation Solutions

Location

Whitesboro

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 I

Reference

JR117940

Expiry date

01/01/0001

Hanna Pitcairn Read more Shortlist Save this role
Biostatistician II

Salary

Location

India

Department

Biometrics Roles

Location

India

Remote Working

Remote

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

2024-107697

Expiry date

01/01/0001

Read more Shortlist Save this role
Assistant Clinical Data Coordinator

Salary

Location

India, Bangalore

Location

Bangalore

Trivandrum

Bengaluru

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Data Management

Job Type

Permanent

Description

Functional Knowledge: • Enhanced functional knowledge level of coding in the context of clinical data management. Business Expertise: • Ability to link enhanced knowledge of Coding to accomplish own w

Reference

JR118021

Expiry date

01/01/0001

Sunidhi Sinha

Author

Sunidhi Sinha
Read more Shortlist Save this role
Senior Clinical System Designer

Salary

Location

South Africa

Department

Biometrics Roles

Location

South Africa

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Data Management

Clinical Data Scientist Lead

Clinical Systems

Data Standards Consultant

Job Type

Permanent

Description

Looking for a Senior Clinical System Designer within FSP model. 

Reference

2024-110479

Expiry date

01/01/0001

Serena Milanesi Read more Shortlist Save this role
Clinical Data Programmer

Salary

Location

Ireland, Dublin

Department

Full Service - Development & Commercialisation Solutions

Location

Mexico City

Dublin

Johannesburg

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Data Management

Programming

Clinical Programming

Job Type

Permanent

Description

Clinical Data Programmer Location:Mexico CityDublin, IrelandSouth AfricaICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance cl

Reference

JR114992

Expiry date

01/01/0001

Jonathan Cunliffe Read more Shortlist Save this role

Browse popular job categories below or search all jobs above