Senior Clinical Trial Specialist – Global Studies

Sr. Study Specialist – Global Study OperationsLocation: San Rafael, CA (Hybrid – Tues & Thurs onsite)Duration: 6 Months Contract Work Model: Hybrid (Offsite + 2 days onsite)Pay Rate: $50/hr to $58/hr (W2) - Based on experienceAbout the RoleThe Sr. Study Specialist (SS) supports and executes global clinical study operations, working closely with Study Managers and Program Leads. This role involves site monitoring oversight, vendor management, and study execution support across the full clinical trial lifecycle.You will play a key role in ensuring patient safety, data integrity, regulatory compliance, and study timelines in a fast-paced and complex clinical trial environment.Key ResponsibilitiesSupport or lead study operational activities across startup, maintenance, and closeout phasesContribute to site feasibility, selection, and activation processesOversee CRO activities, including IRB/EC submissions and approvalsManage trial master file (TMF/eTMF) to ensure inspection readinessCoordinate site & investigator training materials and presentationsTrack and oversee ClinicalTrials.gov updates and complianceHandle vendor management (budgets, SOWs, invoices, performance tracking)Monitor study timelines, risks, and issue escalationsSupport cross-functional collaboration across global teamsEnsure accurate documentation, reporting, and system updatesAssist in audit/inspection readiness activitiesRequired Skills & ExperienceCore CompetenciesStrong communication & cross-functional collaborationAbility to work independently in complex environmentsProactive mindset with strong problem-solving skillsDemonstrated leadership and ownershipTechnical ExpertiseEnd-to-end clinical trial lifecycle experienceStrong understanding of:Study startup, execution, and closeoutRegulatory compliance and GCP standardsClinical development processesExperience with:eTMF/TMF systems (quality & inspection readiness)EDC systemsIRT/IXRS, eCOA/ePRO platformsVendor and site performance tracking (KPIs)Tools: Microsoft Teams, SharePoint, DocuSignEducation & QualificationsBachelor’s degree in Life Sciences, Nursing, or related field (preferred)Equivalent industry experience will be consideredExperience in biotech/pharma clinical operations requiredProven experience managing:CROs and external vendorsStudy budgets, POs, and invoicesIdeal Candidate Profile5–8+ years in clinical study operations or clinical trial managementStrong experience with global trials and CRO oversightComfortable working in a fast-paced, matrixed environmentPrior experience in rare disease or complex trials is a plus