Sr. Clinical Study Manager

Overview In this role you will lead and oversee clinical trials from startup to closeout, ensuring on-time delivery and budget adherence. You collaborate with cross-functional teams and external vendors to maintain data integrity and regulatory compliance. You will manage study documents, budgets, and publication processes, while optimizing clinical operations. This position offers impact through coordinating trials, driving issue resolution, and partnering with science and clinical teams to deliver high-quality results. ResponsibilitiesLead and oversee trials from startup to closeout, ensuring timely delivery and budget complianceCoordinate with functional areas to identify issues and implement timely solutionsIdentify, select, and manage high-quality clinical vendors and FSPS with clear contracting termsOversee vendor performance to ensure data integrity and regulatory adherenceDevelop and finalize study documents (protocols, CRFs, informed consent, study management plans, final reports)Collaborate with finance on milestones, payments, and invoicingFacilitate teleconferences with internal/external groupsSupervise Clinical Trial Coordinator and ensure project plans, trackers, and metrics are maintainedSupport co-monitoring responsibilities as neededCommunicate with PI, Study Co-Coordinator, and CRO to resolve issuesOversee publication process with publications team to meet timelinesMonitor trial status using standard/ad hoc reporting and assign accountability for deliverablesManage milestones and budgets in collaboration with PM and tracking systemsProactively identify issues and escalate to management Key requirements10+ years in clinical trial management with broad knowledge of drug development and clinical operations in Big PharmaAbility to manage multiple projects concurrently with strong organization and planningStrong analytical and problem-solving abilities; communicates issues with action plans to leadershipKnowledge of regulatory standards and guidelines including ICH-GCPExcellent collaboration and teamwork skills; ability to influence and negotiateExceptional verbal and written communication with all management levels and external contactsExperience using Inform database, PowerPoint and ExcelIndependent judgment in functional responsibilities; innovative in optimizing clinical operationsinfluencing and negotiationcross-functional collaborationproblem solvingICH-GCP regulatory knowledgeInform databasePowerPoint