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Manager, Laboratory Project Management

Manager, Laboratory Project Management 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 Manager, Project Management plays a key role within ICON Laboratory Services (ILS) by managing the daily activities of the Project Management Team and ensuring overall client satisfaction by acting as the Client's main contact in all matters and act in an advisory role to those less experienced on the team.      Overview of the Role 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 Laboratory Departments. Review newly assigned Protocols and Amendments. Interpret the Client's Protocol into ILS terms and use this information to complete the Client Laboratory Worksheet (CLW) and communicate information as required to other departments within ILS (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 ILS 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 ICOLabs and provide ongoing support in the use of this online results system. Define and add new tests and supplies into studies w 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 suggest ions 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. Travel (approximately 20%) domestic and/or international  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. Role Requirements Hold a BS or BA in a Life Science or related field. You will possess a minimum of 5 working in a clinical laboratory, clinical trials, or customer management account management role in a life sciences related organization. At least 3 years of Project Managementexperience in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management , or Electronic Data Capture. At least 1 year of mentoring, supervising or leading other staff members. 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. 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 Reference: 054621
Salary Range: NA
Minimum Qualification
Less than 5 years

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