Job TitleJob InformationDate Opened 04/04/2025Job Type Full timeIndustry BiotechnologyWork Experience 4-5 yearsCity ChicagoState/Province IllinoisCountry United StatesZip/Postal Code 62351Job DescriptionEssential DutiesLead all clinical study operations, providing strategic/tactical planning, organization, and direction of study project(s) including but not limited to the oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data collectionFacilitate and foster positive, productive, and timely communication between Sponsor, study team, and other functional groupsManage and motivate study team while serving as a mentor. Mentorship may include identifying skills of the clinical team members and assisting with further professional developmentProvide proper financial oversight of study budget, including out of scope trackingCollaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals (Project Review)Drive the development, maintenance, and distribution of project plans based on project-specific requirements, throughout the life of the study (i.e. monitoring plan, communication plan, project management plan, eTMF plan, other plans as applicable)Manage studies in compliance with GCP, relevant SOPs, regulatory requirements, and project-specific plansAssess resourcing needs to ensure the study has the appropriate resources for the duration of the projectActively manage and track study risks (with team and Sponsor input for potential obstacles that would delay the project's progress while appropriately escalating issuesAssess training needs of team members on the therapeutic area, protocol, special procedures/skills, and implement the appropriate training plansDelegate study team responsibilities and ensure that team members have the necessary tools and resources to effectively perform their roleMonitor and manage the project's progress and develop timelines with input from relevant stakeholders and sponsor approval; re-assess critical path for study progress and adjust timelines as neededOversee activities and deliverables of outside vendors, as requested; ensure communication occurs between outside vendors, the team, and sponsorOther QualificationsOutstanding interpersonal, oral, and written communication skillsProven effectiveness as a team leaderPrior experience successfully managing multifaceted studies from inception through implementation and completionOutstanding organizational and time management skillsExperience managing projects in a virtual environmentDemonstrated ability to lead by example and to encourage team members to seek solutions independentlyRequirementsRN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experienceBenefitsCompetitive payCareer growthFull medical, dental, and vision benefit packages401(k)Commuter benefitsLegal benefitsThe best coworkers, if we do say so ourselves