[Remote] Clinical Study Manager

Note: The job is a remote job and is open to candidates in USA. Cordis, in partnership with Selution, specializes in the development of advanced drug device combination products for treating coronary and peripheral artery disease. The Clinical Study Manager is responsible for the operational management and execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with regulatory standards.ResponsibilitiesLead and manage all operational aspects of assigned clinical studies to ensure successful execution according to protocol, timelines, and GCP/ISO 14155 requirementsDevelop and maintain study project plans, timelines, and risk assessmentsManage site selection, feasibility assessments, and initiation activities in collaboration with CRAs and regional teamsOversee vendor selection, contracting, and performance management for CROs, laboratories, imaging providers, and other external partnersEnsure study budgets are tracked and variances are addressed proactivelyPrepare and maintain essential study documents, ensuring audit readiness and alignment with eTMF standardsMonitor enrollment, data quality, and protocol compliance; implement mitigation strategies as neededConduct cross-functional team meetings and maintain effective communication among study stakeholdersSupport development and review of study protocols, case report forms (CRFs), monitoring plans, and study reportsLead preparation for audits and regulatory inspections related to assigned studiesMentor and provide guidance to junior team members, including CTAs and CRAsContributes to the continuous improvement of clinical operations processes and toolsSkillsBachelor's degree in Life Sciences, Nursing, or related field8+ years of experience in clinical research, including at least 2 years in study managementStrong knowledge of ICH-GCP, ISO 14155, and FDA regulationsProven ability to manage cross-functional teams and multiple global vendorsExcellent organizational, communication, and leadership skillsExperience managing cardiovascular or combination product clinical trialsPrior experience with IDE and PMA submissionsFamiliarity with risk-based monitoring, EDC, eTMF, and CTMS systemsPMP certification or equivalent project management trainingCompany OverviewFrom the first guidewire to the first drug eluting stent, for over 60 years Cordis has remained at the heart of cardiovascular innovation. It was founded in 1959, and is headquartered in Miami Lakes, Florida, USA, with a workforce of 1001-5000 employees. Its website is http://www.cordis.com.