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Project Manager, Laboratory - looking for Research Coordinators/Managers or Central Labs experience!

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About the role

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Project Manager
Farmingdale, NY
 
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Our Project Manager plays a key role within ICON Central Labs by ensuring overall client satisfaction.  Act as the Client’s main contact in all matters regarding ICON Laboratory Services (ILS), provide day-to-day management of studies, attend and represent ILS at Client meetings, provide Clients with regular study updates and communicate study progress to Clients and PM Leadership and manage studies in accordance with Good Clinical Practice.
                                      
Overview of the Role
  • You will act as the Sponsor’s main contact person in all matters regarding ICON’s central laboratory services; following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and the ICON Site Services Department.
  • You will 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. 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.
  • You will 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 the ICON Clinical Division if appropriate.
  • Enter protocol parameter information into PACS/ICOLIMS for new and or amended protocols, prepare and QC clinical study specific materials and when possible, coordinate with other departments for the preparation of study specific materials.
  • Proactively monitor study budget, set the timelines for and monitor the progress of shipment requests for storage samples and verify data.
  • Monitor study progress throughout the study, using ICON tools and communicate pertinent information to clients/sponsors.  Provide Sponsors with study management reports.  Provide client with support on ICOLabs system.  Inform team leader about study progress.  Escalate issues of potential client/site dissatisfaction to appropriate management.
  • Close the protocol as per ILS procedures this includes facilitating Database Lock and coordinating with relevant internal departments.
  • You must be available to travel at least 20% of the time and attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting or Initiations.
Role Requirements
  • You will possess a minimum of 2 years work experience, with one or more years of experience working in a clinical laboratory, clinical trials, project management, customer management or account management role and hold a BS or BA in a Life Science or related field.
  • You will have working knowledge of MS Word, Excel and PowerPoint and possess the ability to multitask, remain composed and even-keeled in stressful situations, and perform effectively in spite of shifting priorities, workload and external pressures.
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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