Project Manager II EDS

Job title:

Project Manager II EDS

Company:

ICON

Job description

Project Manager II EDS – Netherlands, Assen Hybrid: Office/RemoteICON 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 developmentAt ICON Plc, we are a global provider of outsourced development and commercialization services to pharmaceutical, biotechnology, medical device, and government organizations. With a presence in over 90 countries, ICON’s mission is to accelerate the development of drugs and devices that save lives and improve the quality of life.As we continue to grow, we are seeking a Project Manager II to join our EDS team and help drive our success to new heights. This is a 1 year post to over maternity leave and will be based at our Assen site – you will be on site for 70% of the week with home based working an option for the other 30%The Role:As a Project Manager II within the EDS division, your role will be to ensure client satisfaction by acting as the Sponsor’s primary contact person in all matters relating to the conduct of a bioanalytical study including day-to-day management of studies. You will be required to perform the role of Project Leader or Principal Investigator or Study Director, as appropriate on awarded studies, as well as to assist in the development, oversee and approve the validation and subsequent application of bioanalytical methods in support of regulated studies. We would expect you to effectively communicate progress of awarded work to the client and liaise with lab operations on all aspects of the work and to keep accurate projections of work to be performed each month, perform billing for all analyses, and process change orders as required..Key Responsibilities:

• 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.
• Oversee more complex projects (e.g., method validations, endogenous biomarkers, novel methods), which may require close collaboration with Lab Managers.
• Assume the lead in hosting sponsor calls and insure the agenda and meeting minutes are maintained accurately.
• Act as the Project Leader for high profile projects to ensure client satisfaction.
• Assist in the training and/or mentoring of Project Leader I.

Qualifications:Bachelor’s degree (life sciences or related field preferred).Minimum of 3-5 years of project management experience in clinical research, ideally in Early Phase clinical trials.Proven experience managing global clinical trials, with a focus on timelines, budgets, and client relationships.Knowledge of ICH-GCP guidelines, clinical trial regulatory requirements, and operational practices.Strong leadership and interpersonal skills, with the ability to manage multiple priorities and stakeholders.Excellent problem-solving skills and the ability to thrive in a fast-paced environment.PMP certification or equivalent is a plus.Why Join ICON?At ICON, we understand the importance of supporting your career development and progression. We offer:Competitive salary and benefits package.Career progression opportunities and continued professional development.A dynamic, inclusive, and innovative working environment.The opportunity to work with a leading global company in clinical research that makes a tangible difference in people’s lives.Application Process:If you are ready to take on this exciting challenge and contribute to the success of ICON, apply today! We look forward to hearing from you.ICON Plc is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.#LI-SA1What 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 entitlementsA 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 assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.Visit our to read more about the benefits ICON offers.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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 .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.Are you a current ICON Employee? Please click to apply

Expected salary

Location

Assen, Drenthe

Job date

Thu, 12 Sep 2024 01:46:28 GMT

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