ICON Strategic Solutions · 1 month ago
Project Manager I EDS
US, Lenexa KCIB (PRA)
Full-time
Hybrid
Mid Level
3+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Project Manager I EDS to monitor and evaluate bioanalytical projects, manage studies, and ensure compliance with regulatory requirements while maintaining communication with sponsors.
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
Required
A suggested minimum of 3 years' experience in a laboratory or project management role, at discretion of hiring manager
Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance
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
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions 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
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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