ICON plc

Clinical Study Lead

ICON plc$121K — $151K *
US-Anywhere
+ 2 other locationsRemote
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Undergraduate degree in clinical, science, or health-related field; licensed healthcare professional (e.g., registered nurse) preferred.
  • 5 years of relevant experience in clinical trial management.
  • 3 years of experience specifically in managing clinical trials.
  • Fluent in English with proficiency in the language of the host country.

Responsibilities

  • Oversee vendors for budget and timeline adherence during trials.
  • Develop strong relationships with vendors and sites throughout the study phases.
  • Understand and maintain detailed knowledge of study protocols for training and improvement contributions.
  • Coordinate tasks with sponsor roles for study site readiness, including material preparation and drug shipping.
  • Review monitoring reports and CRO deliverables for compliance and oversight.
  • Conduct periodic eTMF/TMF reviews for adherence to standards and regulations.
  • Revise vendor service agreements, budgets, and timelines while ensuring performance meets expectations.
  • Support audit activities and maintain clinical trial registry updates.

Benefits

  • Comprehensive health, dental, and vision coverage.
  • Retirement and pension plans available.
  • Life assurance and disability coverage included.
  • Access to employee assistance and wellbeing resources.
  • Opportunities for structured training and career development.
  • Performance-related incentives alongside competitive base salary.
Full Job Description
Clinical Study Lead - Regeneron

What you will be doing

  • Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives of individual protocols/programs.
  • Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
  • Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
  • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
  • Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
  • Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
  • Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
  • Supports financial management of the study which includes review and approval of site and vendor invoices.
  • Supports risk Management initiatives
  • Supports audit/inspection activities as needed.
  • Maintain clinical trial registry entry/updates, as required.
  • Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.


Your profile

  • Undergraduate degree or its international equivalent preferably in clinical, science, or health related field from an accredited institution; a licensed health-care professional, i.e., registered nurse
  • 5 years of relevant experience including 3 years of experience in clinical trial management
  • Reads, writes and speaks fluent English; fluent in language of host country.

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 to read more about the benefits ICON offers.

Salary Range

$121,576.00-$151,970.00

Are you a current ICON Employee? Please click to apply

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ

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