Project Manager I EDS

ICON plc•Whitesboro, NY

About The Position

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. ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Requirements

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

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.