Clinical Study Manager

Clinical Study ManagerThis position will oversee assigned clinical research projects, protocol development, site management, monitoring, TMF management, cross-departmental collaboration and communication, and documenting and tracking execution of projects to adhere to milestones, budgets, and targeted timelines.Essential Duties and Responsibilities:Manage end-to-end lifecycle of assigned IVD clinical research projects, including startup, site management, monitoring, and closeout.Coordinate IRB submissions, laboratory shipments and incoming samples, sample receipt logging, kit creation and inventory, and ensure study deliverables are achieved on time and within budget.Oversee TMF, CTMS, and database for assigned projects.Participate in development of protocols, ICFs, CRFs, and other study-related documents.Build study budgets and timelines, establish milestones, and coordinate site selection and activation.Track metrics and summarize clinical data for project updates, reports and publications.Serve as the primary liaison between the sponsor, vendor, sites, and internal cross-functional teams for assigned projects.Ensure project compliance with ICH-GCP guidelines, IRB requirements, FDA regulations, and any other applicable requirements.Contribute to the forecasting and management of resources.Identify future potential studies to address unmet needs.Support the onboarding of new technologies, progression of scientific innovation projects, and process improvement initiatives.Perform all other duties as assigned.Qualifications/Requirements:Bachelor's degree in a health or science field required.At least 5 years of experience in clinical research, with specific experience in studies used for FDA/regulatory submission required.Direct trial management experience and prior experience working at the sponsor/CRO level required.Experience in IVD or medical device clinical research strongly preferred.Clinical research certification (e.g. ACRP, SOCRA) strongly preferred.Knowledge of Good Clinical Practice (GCP)/ICH and medical device clinical trial guidelines, rules, and regulations.Understanding of Good Laboratory Practice (GLP), research safety, HIPAA, confidentiality, and regulatory standards & requirements.Strong organizational skills and attention to detail.Ability to work autonomously and strong decision-making skills.Excellent written and verbal communication skills.Ability to travel overnight and out-of-state occasionally (20%)Physical Requirements/Working Conditions/Equipment Used:Office reachable by elevator but should be able to climb stairs if neededLight lifting may be required (up to 25 pounds)Ability to work in an environment with exposure to hazardous chemicals and biohazardsAbility to operate a computer throughout course of dayGeneral office and HVAC noise & fluorescent and/or LED lighting