Project Manager I EDS - US, New York, NY, Whitesboro Hybrid: Office/Remote ICON plc is a world-leading healthcare intelligence and clinical research organization.
We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Project Manager I EDS to join our diverse and dynamic team.
What You Will Be Doing: 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.
Your Profile: A suggested minimum of 3 years' experience in a laboratory or project management role, at discretion of hiring manager.
What ICON can offer you: Our success depends on the quality of our people.
That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits.
Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include: 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.
Visit our careers site to read more about the benefits ICON offers.
At ICON, diversity, inclusion & belonging are fundamental to our culture and values.
Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities.
We're proud of our diverse workforce and the work we've done to become a more inclusive organisation.
We're dedicated to providing an inclusive and accessible environment for all candidates.
ICON is committed to providing a workplace free of discrimination and harassment.
All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements?
We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Salary range: - Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.
You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.
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