Senior Clinical Data Risk Analyst

Posted 8 Hours Ago
Be an Early Applicant
2 Locations
In-Office or Remote
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Leads clinical data risk management and central monitoring for multiple clinical studies. Responsibilities include evaluating trial data for risks and trends, selecting KRIs, overseeing signal tracking and quality control, analyzing discrepancies, developing mitigation strategies, supporting data governance and compliance, coordinating stakeholders, and mentoring junior staff.
Summary Generated by Built In
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.

Are you a current ICON Employee? Please click here to apply

Skills Required

  • 5+ years of experience in clinical data analysis or risk management within a clinical research organization or pharmaceutical company
  • Strong analytical skills and proficiency in statistical software and risk assessment methodologies
  • Knowledge of at least one clinical data management system, such as Medidata RAVE, InForm, Veeva, Cluepoints, Medidata Detect, or JReview
  • Bachelor’s degree or local equivalent
  • Fluent English and host-country language proficiency in reading, writing, and speaking
  • Legal right to work in the country where the role is based
  • Life sciences or related field degree

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

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.

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