ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
At ICON, we have an incredible opportunity for a Manager, Laboratory Project Management to join the team in our Leopardstown, Dublin 18 location.
The Role:
To manage the daily activities of the PM team per the direction of the Manager, PM. To ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Central Laboratories' (ICL) services, and act in an advisory role to those less experienced on the team.
Responsibilities:
Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 20%) domestic and/or international
• Act as the Client's main contact in all matters regarding central laboratory services, following up and responding to study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and all internal ICL Departments.
• Review newly assigned Protocols and Amendments. Interpret the Client's Protocol into ICL terms and use this information to complete the Client Laboratory Worksheet (CLW) and communicate
information as required to other departments within ICL (and ICON Clinical Research (ICR), if working on a jointly awarded study).
• Enter protocol parameter information into PACS/LIS/ICOLIMS systems for new and/or amended protocols. Prepare and QC clinical study specific materials.
• Responsible for preparing study specific presentation material and attending and representing ICL at Investigator Meetings, Kick-Off Meeting, Site Initiations, Lessons Learned and any other client meeting required.
• Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study specific Communication and Escalation Plan.
• Train Clients on I CO Labs and provide ongoing support in the use of this online results system.
• Define and add new tests and supplies into studies with Client authorization.
• Proactively manage and track study progress, lab reporting or logistical issues, and perform risk management using a variety of internal management reports and the tools available.
• Provide Clients with regular study updates via a variety of reports from PACS, ICOLabs, the CRM and beyond, reporting and escalating trends, issues, or any deviations from the protocol either at the site
level or internally. Forecasting and communicating study progress in a responsible and professional manner.
• Participates in teleconference/communication with Clients - either routine updates or discussion of specific issues.
• Manage issues escalated from Site Services and other internal groups, including problem-resolution, reporting trends, escalating outstanding queries and abnormal values to the Client and managing changes at database lock.
• Responsible for setting the timelines for and monitoring the progress of shipment requests for storage samples including data verification.
• Gathers and collates sponsor requested metrics.
• Interface with Business Development as needed for proactive monitoring of study budget.
• Responsible for documenting correspondence with all Clients and maintaining study specific files to ensure that all appropriate documents are properly maintained, ensuring all necessary documents are archived at study closure.
• Review new or updated SOPs as they are published to ensure they remain relevant, current and are being followed. Recommend policies, procedures and processes to ensure that a high level of QC and QA is maintained.
• Work to enhance team tools and practices by actively recommending suggestions for improvements in efficiency and regular study progress to the Manager, PM.
• Draw from study management experience to recommend process improvements on best practices for communication and escalation and issue resolution.
• Provide feedback to the Business Development team regarding key clients
• Performs additional relevant responsibilities as requested by management
• Lead regular team meetings.
Supervision:
• Coach, mentor and develop direct reports. Delegate work to direct reports as appropriate.
• Evaluate the performance of direct reports and establish mutually agreeable goals and timelines.
• Coordinates the day to day on the job training of new Project Managers.
• Performs performance reviews, aids in goal setting and career development for team members.
• Approve/reject requests for Paid-Time-Off (PTO). Update labor tracking system(s) accordingly. Reconcile
PTO
What you need:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Working familiarity with Word, Excel, PowerPoint
• Excellent Oral and Written Communications
• Ability to Multi-Task
• Ability to remain composed and professional in stressful situations, performing effectively with shifting priorities, workload and external pressures.
• Excellent Presentation Skills
• Organizational Agility
• Ability to work with, and maintain the confidentiality of customer proprietary information.
• Mastery in following established processes and use of all PM tools
• Knowledge and familiarity with the clinical trials industry.
• Ability to successfully perform job functions with little or no supervision.
• Ability to effectively apply learned principles to broader situations.
• Proven ability to proactively manage a broad variety of clinical studies
• Proven ability to utilize all resources and successfully navigate the organization for optimal study management
• In depth proven experience working in a clinical laboratory, clinical trials, or customer management/account management role in a life sciences related organization*.
• Prior relevant experience successfully performing the Project Management role in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management, or Electronic Data Capture.
• Prior relevant experience mentoring, supervising or leading other staff members.
• Successful management in providing technical services for more than 20 clinical trials, including: presentation at Investigator Meetings, implementation of protocol amendments, completion of laboratory configurations, trial reconciliations, participation in sponsor/regulatory audits, bid defences.
Education:
• BS/BA Science, Business or related Field*
An alternative combination of experience, education, and training determined by management to be equivalent to the foregoing.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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 through the form below.
