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ICON plc · 4 days ago

Project Manager I EDS

New York, NY

Full-time

Hybrid

Mid Level

$69K/yr - $86K/yr

3+ years exp

ICON plc is a world-leading healthcare intelligence and clinical research organization. They are currently seeking a Project Manager I EDS to join their diverse team, responsible for managing bioanalytical projects, ensuring compliance, and maintaining communication with clients throughout the study process.

Biotechnology

H1B Sponsor Likely

Responsibilities

Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance

As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs

Travel (approximately 1%) domestic and/or international

Monitor and evaluate bioanalytical projects progress with respect to milestones, budgets and timelines

Manage bioanalytical studies to ensure that bioanalysis is well coordinated with in life study phases, and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period

Work with laboratory management to ensure that appropriate resources are available to complete the study to timeline

Obtain all client specific documents required for the analysis; i.e., study protocol, randomization lists, COA, demographics, etc. Review protocol and amendments to assure adherence to specifications and regulatory requirements

Prepare analysis plans suitable to the client’s needs, as specified by contract, and obtain client approval of these

Work with laboratory operations to ensure compliance to study and validation plans

Provide Sponsors with regular updates, forecasting and communicating study progress. Timely reporting of any significant deviations

Ensure that project delivery, reporting specifics, and timelines as agreed are met. Inform laboratory operations, DM and QC/QA of deadlines

Maintain records of work conducted in a timely and consistent manner, sufficient to allow real-time tracking of deliverables, including tracking of revenue and resources associated with assigned studies

Identify changes to scope of work as defined by contract and ensure that change orders are processed prior to work being executed

Review and approve all data in accordance with direction documents and ensure results are documented accurately, completely and compliant with GxP regulations and SOPs. Initiate investigations and event deviations as necessary

Proactively identify possible/potential implications of unusual results, work with laboratory staff to investigate and report findings

Prepare reports of the work conducted, address all QA findings and provide QA draft report in line with the terms and conditions stated in the signed contract

Ensure that all documentation is appropriately archived on completion of the study

Review and approve laboratory notebooks and other analytical data as required

Maintain awareness of and adherence to all current SOPs

Work in compliance with GLP/GCP

Any other duties related to maintaining the provision of the Laboratory Analytical Services

Qualification

Bioanalytical StudiesGxP ComplianceProject ManagementLaboratory OperationsCommunication Skills

Required

A suggested minimum of 3 years' experience in a laboratory or project management role, at discretion of hiring manager

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs.

Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Company

ICON plc

Glassdoor3.7

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.

Founded in 1990

Dublin, IE

10001+ employees

http://www.iconplc.com

H1B Sponsorship

ICON plc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (4)

2024 (4)

2023 (5)

2022 (11)

2021 (4)

2020 (5)