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Senior Clinical Project Manager

Company: CareFusion
Location: Franklin Lakes
Posted on: January 16, 2020

Job Description:

Job Description Summary Job Description The Senior Clinical Project Manager working within the International Clinical Operations team as part of the Global Clinical Development (GCD) organization, is responsible for clinical trial management of multiple studies in countries outside of North America and Europe. He/she may function as local subject matter expert for a group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by GCD or Contract Research Organizations (CRO). The Senior Clinical Project Manager may also serve as mentor to other local clinical team members. This role serves as the local project lead in a multitude of countries for studies of various complexity and supports protocol development through study conduct and closeout in compliance with Good Clinical Practices, global, national and local regulations, BD and GCD policies, and SOPs. The role reports to the Director International Clinical Operations at GCD and collaborates with respective global GCD functions, e.g. DM and Statistics, and GCD Project and Portfolio Managers to ensure an aligned planning and optimized trial execution. Responsibilities - Works with limited supervision and direction, prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters). - Ensures execution within overall study timelines and deliverables and delivers accordingly for his/her studies. - Collaborates actively with other GCD functions, e.g. global project management, as applicable, DM and Statistics - Oversees/leads and trains study-specific local clinical resources, e.g. contractor CRA, CRO, etc. - Manages studies across business units - Mentors other clinical study team members as needed - Provides critical thinking and escalates accordingly when issues arise during execution of clinical studies. - Contributes to continuous improvement activities/initiatives - Manages relationships with sites/PIs and other study-related vendors, e.g. CROs, central labs, etc. - Functions as GCD contact person for the respective local BD organization - Has good knowledge of established project management standards to be able to plan and track regional study tasks accordingly (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions with the global project manager or other stakeholders as needed. - Defines, tracks and reports on project management schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff - Weighs in on resource and budget forecasts and timelines - Proactively identifies, escalates and manages risks and issues to ensure cost-effective timely delivery of the project - Oversees study quality and implements high quality standards in order to meet compliance requirements - All other duties as assigned Requirements: - Bachelor's degree required, preferablyin the life sciences, clinical or other relevant technical areas - Minimum of 4 years project management experience - Minimum 6 years of clinical study experience, in medical device, or in IVD, pharmaceutical, biotechnology, CRO) including the proven ability to oversee clinical teams in the conduct and report of multicenter, global complex studies - Knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulations - Strong client and vendor relationship management skills - Ability to work effectively, mostly independently in international teams, manage multiple projects and work in a fast paced and changing environment - Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences - Ability to work virtual/remote if candidate has previous experience working effectively in a virtual/remote environment - Ability to travel approximately 30%, worldwide Primary Work LocationUSA NJ - Franklin Lakes Additional LocationsUSA RI - Warwick Work ShiftNA (United States of America)

Keywords: CareFusion, New York , Senior Clinical Project Manager, Healthcare , Franklin Lakes, New York

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