ProClinical is partnering with a workforce management solution company to advertise a vacancy for a Remote Project Coordinator. This job, based in New Jersey, will be with one of the largest and most innovative business and talent strategy organisations in the world.
Job Responsibilities: Providing project management and leadership to Medical Operations staff. Coordinating the literature process, such as working with vendors in execution of literature searches, full-text ordering, and requesting translations. Actively partnering with cross-functional business partners, such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs related to the CER/Literature process. Collaborating with and supporting the Medical Operations Leadership team through the various processes. Maintaining and executing project management tools, such as Microsoft project plans and Lean Kit boards and actively communicating project milestones/task levels with writing staff and vendors. Ensuring that strategic plans for operation company CER/literature timelines are met and practices are being consistently deployed across the global organisation. Maintaining and monitoring metrics relevant to the Medical Operations team activities, such as CERs, Literature Searches, Literature Reviews, Compliance Activities, providing visibility of issues, and enabling corrective and preventive actions to be taken as needed. Maintaining a knowledge and access to applicable MD Quality systems to support the teams in document retrieval and routing of Medical Operations documents for approval. Providing support to the Leadership team during audits and inspections pertaining to CER processes and reports.
Skills and Requirements: A bachelor's degree in a technical discipline is required. At least three years of related job experience. Demonstrable knowledge and experience in project management principles and methodologies is required. Demonstrable experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is preferred. Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems. Demonstrable multitasking, project management, and execution skills. Good interpersonal skills, including communication, presentation, persuasion, and influence. Good organisational skills, including efficiency, punctuality, and collaboration in a team environment. Proficiency in MS Office.