Sr. Study Specialist, Global Study Operations

Are you an experienced Sr. Study Specialist, Global Study Operations with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Sr. Study Specialist, Global Study Operations to work at their company in San Rafael, CA.Position Summary: The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study-related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and managing more challenging or complex vendors, sites, and regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate proficient knowledge and experience in the following competencies: Primary Responsibilities/Accountabilities:The client is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. The client aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative therapeutics, advancing the standard of care, and providing personalized support and services globally. The Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.Develop study-specific documentation, as delegated by the Study ManagerContribute to the oversight of country and site feasibility assessment and site selection.Oversight of CRO for IRB/EC-related submission/approval activitiesOversight of essential documents for study life-cycle managementDevelop/Oversee site and investigator training materialsPresent at investigator meetings as assignedEnsure accurate and timelyOversight of Clinical Trial InsuranceAttend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) asOversee and manage study entry and updates to ClinicalTrials.govFacilitate Screening Authorization Forms sign off and oversee tracking, where applicableProcess documents for signature in DocuSignContribute to Global Study Operations risks identification and mitigation.Provide support and administrative assistance with internal and external meetingsEnd-to-end study operational understanding to support across start-up, maintenance, and close-out activities. (in a fast-paced, complex clinical trial environment)Proficient understanding of clinical trial lifecycle milestones, critical path dependencies, and inspection-readiness expectations.Ability to independently work in complex operational workstreams with minimal oversight, Systems & PlatformsQualifications:BA/BS or higher in nursing, life, or health sciences is preferred. Industry or relevant experience in lieuof education is considered.Experience in a biotechnology or pharmaceutical company, oversight of external vendors, includingSOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging, etc.TMF/eTMF systems (quality, completeness, and inspection readiness)EDC experience (operational interfaces, timelines, and dependencies)IRT/IXRS and eCOA/ePRO operational support as applicableTracking vendor milestones, site activities, and KPIsFamiliar with TEAMS and SharePoint PlatformStrong discipline in system accuracy, reconciliation, and data integrity.Preferred:Agility and ProactivityLeadershipCommunication and CollaborationStudy Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area Knowledge

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