The Role
The Project Manager II will manage client relationships, oversee clinical study processes, ensure compliance, and enhance team tools while managing project timelines and budgets.
Summary Generated by Built In
Project Manager II, Laboratory- hybrid- Farmingdale NY or Blue Bell PA
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. The Project Manager will ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Laboratory Services (ILS), including the setup and day-to-day management of studies, attend and represent ILS at Client meetings, manage studies in accordance with Good Clinical Practice, provide Clients with regular study updates and communicate study progress to Clients and PM Leadership in a responsible and professional manner, represent Project Management at internal interdepartmental meetings or interdivisional meetings within ICON, help train more junior PMs, act in an advisory role to those less experienced on the team, and work to enhance team tools and practices by actively recommending suggestions for improvements in efficiency, serve as the tactical site supervisor for project manager in the absence of a Team Lead for work related and administrative tasks and take on additional responsibilities to enhance the overall PM Team tools and Practices, as defined by Management.
Overview of the Role
- Recognize, exemplify and adhere to ICON's values which centers 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 <20%) domestic and/or international
- Act as the sponsor's main contact person in all matters regarding our 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.
- 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).
- Enter protocol parameter information into PACS//ICOLIMS and other systems for new and/or amended protocols. Prepare and QC clinical study specific materials.
- 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. 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. Provide client with support on ICOLabs system. Inform team leader about study progress.
- Proactively monitor study budget.
- 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 Initiations.
- Develop new tools, train new employees.
- Performs additional relevant responsibilities as requested by management.
Role Requirements
- Bachelor's degree or local equivalent in Science, Business or related Field
- Minimum of 2 years of experience working in a clinical laboratory , clinical trials, or customer management/account management role in a life sciences related organization
- Minimum of 1 years of Project Management experience in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management, or Electronic Data Capture.
- 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 laboratory PM tools (e.g. configuring laboratory databases, tracking results, ordering supplies, )
- 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
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Top Skills
Icolims
Excel
Microsoft Powerpoint
Microsoft Word
Pacs
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The Company
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
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