Study Manager

Industry: Pharmaceuticals Title: Sr. Study Specialist, Global Study OperationsJob ID: 36428598Location: San Rafael CA (Hybrid)Duration: 12+ months contract (+Possibility of extension)Job DescriptionClient 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. Client aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative Client therapeutics, advancing the standard of care, and providing personalized support and services globally.The Client 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.Role SummaryThe 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 manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:Core Competencies:Agility and ProactivityLeadershipCommunication and CollaborationTechnical Competencies:Study Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area KnowledgeResponsibilities include but are not limited to: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 timely study entry and updates to ClinicalTrials.govFacilitate Screening Authorization Forms sign off and oversee tracking, where applicableProcess documents for signature in DocuSignOversight of Clinical Trial InsuranceAttend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.Oversee and manage essential documents in the Trial Master File (TMF)Contribute to Global Study Operations risks identification and mitigations.Provide support and administrative assistance with internal and external meetingsSkills:Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.).Education:BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.

Created: 2025-10-05