Senior Project Manager, Laboratory

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Job description

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.

*The Role:*

* Act as the sponsor's main contact person in all matters regarding our central laboratory services, following up to and responding to clinical study specific inquiries from a range of internal & external stakeholders.
* Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Laboratories (and ICON Clinical CRO if appropriate).
* Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study Project Management Plan
* Ensure adherence to the protocol specific monitoring plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained. Ensure that all necessary documents are archived at study closure.
* Provide Sponsors with study management reports as required and agreed. Provide client with support on ICOLabs and iSite systems.
* Proactively monitor study budget through monitoring of Protocol Tracking reports and other tools provided to assist
* Regularly use the PM Dashboard to help monitor study progress and communicate to Sponsors in a timely manner if issues identified may require further investigation
* Set the timelines for and monitor the progress of shipment requests for storage samples and verify data.
* Attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting, Bid Defenses or Face to Face Governance meetings.
* Serve as a leader, mentor and consultant to more junior team members in resolving issues or questions as they arise.
* Serve as a gateway for escalation of PM issues to PM Manager and Senior/Executive Management

*To be successful in the role, you will ideally have:*

* 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 a 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.
* Successful management in providing technical services for multiple clinical trials, including Presentation at Investigator Meetings, Implementation of protocol amendments, Completion of Laboratory Configurations, Trial reconciliations, Participation in sponsor/regulatory audits, Bid Defences
* Bachelor's degree or local equivalent in Science, Business or related Field and/ or an alternative combination of experience, education, and training.

*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, 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 through the form below.