Project Manager

Summary The Project Manager is responsible for oversight of assigned clinical studies.  The Project Manager will participate in development of Statements of Work (SOW) to define client expectations, and will perform duties associated with day-to-day oversight of ongoing clinical trial study projects, throughout the life of the trial to ensure quality deliverables on time and within budget. Responsibilities Provides ongoing oversight for clinical trial projects assigned, including client meetings and communications, report development and review, issue resolutions, and budget oversight. Monitors scope of services and proactively initiates scope revision and change order process. Primary project contact with Sponsors and Contract Research Organizations to ensure appropriate communication channels are maintained and reporting schedules adhered to. Serves as first point of contact for management issues related to clinical trials. Identifies and monitors potential risks and proactively works on mitigations Works closely and in coordination with clinical laboratory management and directors in support of clinical trials. Review of reports and documents, including enrollment logs, pending test reports, reporting from other laboratories, issue logs, shipping manifests, and other documents that assist with study oversight. As needed, interfaces with laboratory(ies), BD, Technical Affairs, Vendor Management, and Data Management. Liaise with Project Coordinators to ensure study-related tasks have been performed, and with the assigned data manager to ensure data is delivered on time per the SOW. Review and analyze operational, quality, and performance related metrics to assess the success of study oversight activities. Liaise with managers/supervisors in other departments to stay informed of operational changes. Collaborate with project managers in partner laboratories to provide a global overview of study management. Coordinate requests for shipment of stored samples as directed in the SOW. Ensures that all laboratory requirements outlined in the protocol are managed per expectations and in compliance with laboratory practices. Creates training materials for investigator meetings as applicable. Represents LabConnect at client and/or investigator meetings. Performs other related duties and tasks as necessary or as assigned. Education and Qualifications Scientific degree, preferably in a laboratory or life science, or equivalent combination of education and experience. Strongly preferred: Medical Technology or MLT/MTL degree with 3+ years related laboratory experience, or experience in the clinical trial industry in a project oversight role. Excellent organization, communication, multitasking and interpersonal skills. Customer service/client relationship management skills   Language Ability Business fluent in English. Computer Skills Knowledge of Microsoft Office applications including word processing, spreadsheets, and PowerPoint.  SharePoint and Microsoft Project experience a plus. Supervisory Responsibilities Some supervision of employees in the Early Development/Scientific Operations department may be required.  Required Travel Ability to travel up to 20% required.   This job description should not be construed to imply that these requirements are the exclusive standards of the position.  Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.