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Senior Clinical Data Risk Analyst

Role overview

Qualifications

  • 5+ years of experience in clinical data analysis or risk management in a clinical research organization or pharmaceutical company
  • Strong analytical skills with proficiency in statistical software and risk assessment methodologies
  • Knowledge of at least 1 Clinical Data Management System
  • Bachelor’s degree or local equivalent (in life sciences or related field preferred)

Responsibilities

  • Signal tracking, system user support, and communication of trends to internal and external stakeholders
  • Conducting QC and oversight activities within the Central Monitoring team
  • Leading the evaluation of clinical trial data to identify potential risks and trends that may impact study outcomes
  • Collaborating with cross-functional teams to develop and implement risk mitigation strategies that enhance data quality and integrity

Key facts

Other skills

  • Communication
  • Collaboration
  • Detail Oriented

About the company

ICON plc logo

ICON plc

Contract Research Organizations (CRO)

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Company details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

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Job description

Senior Clinical Data Risk Analyst - United States (Remote)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


We have an incredible opportunity for a Senior Clinical Data Risk Analyst to join ICON’s Full-Service IOD Clinical Risk Management team. The Senior CDRA is a clinical risk management and central monitoring functional lead of multiple moderate complexity studies. The CDRA is responsible for clinical data analysis components of clinical studies, including RBQM facilitation, planning, selection of KRIs focusing on identified risks, advanced analytics design and programming specifications, review of centrally aggregated data to identify risk and issues impacting data integrity, patient safety, and regulatory compliance.

Locations: United States (Remote)

What you will be doing:

  • Signal tracking, system user support, and communication of trends to internal and external stakeholders
  • Conducting QC and oversight activities within the Central Monitoring team
  • Leading the evaluation of clinical trial data to identify potential risks and trends that may impact study outcomes
  • Collaborating with cross-functional teams to develop and implement risk mitigation strategies that enhance data quality and integrity
  • Overseeing the analysis of data discrepancies and inconsistencies, providing insights to inform decision-making processes
  • Providing guidance on best practices for data governance and compliance within clinical research
  • Establishing partnerships with stakeholders to ensure alignment on risk management processes and data quality standards
  • Providing mentoring for junior staff

Your profile:

  • 5+ years of experience in clinical data analysis or risk management in a clinical research organization or pharmaceutical company
  • Strong analytical skills with proficiency in statistical software and risk assessment methodologies
  • Attention to detail and a proactive approach to identifying and addressing data risks
  • Knowledge of at least 1 Clinical Data Management System (Medidata RAVE, InForm, Veeva, Cluepoints, Medidata Detect, JReview, etc.)
  • Ability to manage multiple studies simultaneously while handling changing priorities and competing deadlines
  • Excellent written and oral communication skills
  • Bachelor’s degree or local equivalent (in life sciences or related field preferred)
  • Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write, and speak fluent English and host country language.

* Please submit all applications in English

#LI-Remote

#LI-TP1


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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Marcus Rivera

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