Clinical Project Manager

SummaryThe role of this Remote Clinical Project Manager (CPM) is to ensure that the project is planned and conducted in accordance with relevant rules and regulations. The CPM will also need to ensure overall success of the study trial, ensuring that the project is planned and conducted in accordance with all relevant rules and regulations, including the contract, company SOPs, ICH-GCP, FDA and other regulatory guidelines as applicable. The CPM will also ensure that the project meets quality, budget, and timeline objectives, including identifying project milestones and key deliverables.To be successful in this position the CPM must be comfortable collaborating and communicating with a variety of colleagues and clients and demonstrate flexible and creative leadership.QualificationsBachelor's degree in a life science, nursing, computer science or related discipline OR RN/LPN with related experiencesFamiliarity with database program(s), data management, medical terminology; experience working with clinical trial dataKnowledge of FDA regulations and GCPAccuracy, attention to detail and ability to set priorities and meet deadlinesProficient Computer Skills required: Microsoft Office Suite, including Word PowerPoint, Excel with the ability to create and/or utilize V-lookups, pivot tables, formulas, manipulating data and creating reportsOther Skills required:Excellent time management and social skillsHighly motivated with a phenomenal eye for detail WORK ENVIRONMENT This is a remote position with some travelMust have a dedicated office space to work remotely when not onsiteMust be willing to travel throughout North America, and potentially outside of North America (on occasion) in order to perform work dutiesWork environment will include hospitals, medical clinics, and other medical institutionsMust be willing to travel by plane, train, automobile, or as needed depending on work locationsMust be willing to adapt to frequent last-minute travel and schedule changes, as well as itinerary changes to meet the needs of the company and studyWilling to wear Personal Protective Equipment (PPE) as required when visiting medical facilitiesDuties and Responsibilities Clinical Project Manager is responsible for: overall success of the study trial, including the following:Ensuring that the project is planned and conducted in accordance with all relevant rules and regulations, including the contract, company SOPs, ICH-GCP, FDA and other regulatory guidelines as applicableEnsuring that the project meets quality, budget, and timeline objectives, including identifying project milestones and key deliverablesOversight of functional groups and all clinical monitoring team members throughout the duration of each clinical trialEnsuring clear client and internal team communication, process documentation and compliance with procedures set forth by Tranquil Clinical research and its clientsOversight and management of all vendors, including contract negotiations as applicableSetting up CTMS and other study systems for the project and ensure that data is captured/entered in a timely mannerDeveloping and implementing the project plan, and review/approval all study plansTraining, supporting, guiding, and motivating the project teamCoordinating the project team and its activities to achieve contracted deliverablesMonitoring and triggering investigator payments on a timely basisEnsuring project financial trackingPreparing Weekly and Monthly Status Reports (as required)Adjusting resources as needed to meet the Project PlanIdentifying out of scope work and initiating the change order processSet-up the project teamIdentify and document Client requirementsIdentify project milestones and key deliverablesDevelop and implement the Project PlanEnsure all appropriate departmental plans are in placeDevelop and implement the communications and reporting planReview all appropriate study documentationSet-up CTMS for the project with Executive Super User and ensure timely data entryIdentify, train, support, guide and motivate the project teamCoordinate project team and its activities to achieve contracted deliverablesManage Client expectationsMaintain regular contact with ClientInitiate and manage Client invoicing processReview vendor invoicesMonitor and trigger investigator payments on a timely basisUpdate financial trackingMaintain project profitabilityWeekly and Monthly Status Reports (if required)Adjust resources as needed to meet the Project PlanIdentify out of scope workInitiate the change order process