1676-1 Sr Study Specialist

Hybrid: San RafaelSr. Study Specialist, Global Study OperationsThe company 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 company aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative company therapeutics, advancing the standard of care, and providing personalized support and services globally.The company's 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 followingcompetencies: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 materials present at investigator meetings as assignedEnsure accurate and timely Oversight of Clinical Trial InsuranceAttend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as Oversee and man study entry and updates to Facilitate Screening Authorization Forms sign off and oversee tracking, where applicableProcess documents for signature in DocuSignContribute to Global Study Operations risks identification and mitigations.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 & Platforms Proficient use of core clinical systems, including: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.Education & ExperienceBA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.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.The hiring range for this position is $52 to $58.62/hr per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.