Senior Clinical Trial Manager

Job Title: Study Manager (Clinical Operations)Location: California****DEVICE EXPERIENCE PREFERRED****Company Overview:A well-established, global clinical research organization is seeking an experienced Study Manager to lead the delivery of complex clinical trials. The company is known for its scientific expertise, collaborative culture, and strong track record in innovative clinical development programs.Position Summary:The Study Manager will be responsible for the end-to-end operational delivery of clinical studies, ensuring timelines, quality standards, and budgetary targets are met. This role requires strong leadership, vendor oversight, and cross-functional coordination, with a particular focus on driving study execution in a fast-paced environment.Key Responsibilities:Lead the planning, execution, and close-out of clinical trials across multiple sites and regionsDevelop and manage study timelines, budgets, and resource plansOversee CROs, vendors, and third-party partners to ensure high-quality deliveryAct as the primary point of contact for cross-functional study teamsEnsure compliance with protocol, ICH-GCP, and regulatory requirementsIdentify and mitigate study risks, escalating issues as neededMonitor study progress, KPIs, and deliverables, ensuring adherence to milestonesCoordinate internal stakeholders including Clinical Operations, Data Management, Regulatory, and Medical teamsSupport study documentation, including protocols, study plans, and reportsLead study team meetings and provide regular updates to senior leadershipQualifications:Bachelor’s degree in life sciences or related field (advanced degree preferred)5+ years of experience in clinical research, including study management experienceStrong knowledge of global clinical trial processes and ICH-GCP guidelinesExperience managing vendors and external partnersProven ability to lead cross-functional teams and manage multiple prioritiesExcellent organizational, communication, and stakeholder management skillsPreferred Experience:Experience in CNS, rare disease, or complex therapeutic areasBackground working within a CRO or fast-paced biotech environmentFamiliarity with decentralized or hybrid trial modelsStrong risk management and problem-solving capabilitiestbacchus@barringtonjames.com