ICON plc

Clinical Study Lead (CTM II)

ICON plc$121K — $151K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Undergraduate degree or equivalent in clinical, science, or health-related field; licensed healthcare professional preferred.
  • 5 years of relevant experience with 3 years in clinical trial management.
  • Fluency in English and the language of the host country is required.
  • Experience in vendor and site relationship management is advantageous.

Responsibilities

  • Oversee vendor adherence to budget and timelines across clinical trial protocols.
  • Develop and maintain strong relationships with vendors and study sites throughout the trial.
  • Ensure in-depth understanding of study protocols to contribute to team knowledge and best practices.
  • Coordinate tasks for site readiness, including study material and drug approval processes.
  • Review CRO monitoring reports and associated deliverables for sponsor oversight and compliance.
  • Conduct periodic reviews of CRO eTMF/TMF for adherence to standards and regulations.
  • Support the financial management of studies, including invoice review and approval.

Benefits

  • Competitive and comprehensive total rewards package for health, wellbeing, and career development.
  • Health and wellbeing programs including medical, dental, and vision coverage.
  • Retirement and pension plans to support long-term financial planning.
  • Life assurance and disability coverage for peace of mind.
  • Employee assistance programs and wellbeing resources for personal support.
  • Learning and development opportunities with structured training and career pathways.
Full Job Description
Clinical Trial Manager II (Warren, NJ, Armonk, NY or Cambridge, MA)

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.


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.

  • This is a hybrid role - office based three days per week in Warren, NJ, Armonk, NY or Cambridge, MA


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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