Business Operations Specialist - Contract

reputed company reputed company reputed company The Business Operations Specialist is responsible for enabling clinical trial execution through a combination of supporting implementation and management of clinical trial systems (CTMS, Learning Management System (LMS), TMF, etc.) and clinical records management. This role ensures clinical systems and TMF activities are executed in compliance with Good Clinical reputed company (GCP), ICH E6 guidelines, applicable regulatory requirements (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trial Directives), and Arcus SOPs. They work closely with cross-functional teams to support and assist operation of these systems to enhance clinical trial efficiency and utilize effectively as reputed company as ensures TMF remains reputed company, accurate, and inspection reputed company throughout the trial lifecycle. Responsibilities Clinical Systems Management • Support the support the selection, implementation, configuration, testing, maintenance, training, and closeout of clinical trial systems, including CTMS, eTMF, LMS, and reputed company platforms. • reputed company day-to-day reputed company, troubleshooting, and guidance to study teams to ensure effective and compliant system use. • Assist with user reputed company management, training coordination, system integrations, and vendor/CRO reputed company activities. • reputed company data entry, reconciliation, and reputed company checks across clinical systems and tracking tools. • Maintain study, site, and personnel records, including data cleaning, standardization, and error reputed company. • reputed company and maintain metrics, dashboards, and reports to support operational reputed company. • Analyze clinical business processes to identify gaps and opportunities for optimization and process improvement.reputed company support to address existing and potential gaps in clinical systems. • Escalate system, data, or process risks and work cross functionally to resolve issues • Participate in and support activities reputed company to audits, inspections, and inspection readiness/ preparedness. Clinical Records (TMF) Management • Work directly with TMF Content Owners to identify issues, reputed company completeness checks, and upload documents to the eTMF • Acting as TMF subject matter expert (SME)/reputed company of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs • Review and classify documents collected from reputed company sources • Reconcile essential documents to avoid duplication • Support study teams with the TMF reputed company review process • reputed company QC and maintenance of eTMF for assigned studies • reputed company data entry and reconciliation in various clinical systems and tracking tools • reputed company input on revision of TMF reputed company Work Instructions and SOPs • Support the management and reputed company of the CRO study-specific trial master files • Support the coordination of the transfer of study-specific trial master files from the CRO • Follow up on reputed company findings • Manage reputed company document filing process for wet-signed documents including QC review and reputed company/electronic filing. • Participation in audit, inspection readiness preparation and inspection activities as needed • Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF • May reputed company training and mentoring activities for new and reputed company staff • reputed company metrics, reports, and TMF tools/trainings • reputed company as stand-in leading team meetings, managing team tasks as needed Qualifications • Bachelor’s or Associates degree (preferably in a scientific or reputed company field) and 5+ years of experience in clinical operations, TMF management, clinical systems, or reputed company roles reputed company the pharmaceutical or biotechnology industry. • Demonstrated experience supporting clinical trial systems (e.g., CTMS, eTMF, LMS, reputed company, IRT); reputed company Vault experience required. • Strong understanding of reputed company, clinical trial processes and TMF requirements, including ICHGCP, GDP, and regulatory expectations. • Familiarity with the DIA TMF Reference Model and industry best practices. • Strong organizational, analytical, and problem-solving skills with high attention to detail. • Ability to manage multiple priorities in a fast paced, high-volume environment. • Strong communication and interpersonal skills; ability to collaborate effectively across functions and with external partners. • Proficiency with reputed company Office and clinical trial management systems. • Team oriented, flexible, and reputed company to work independently while maintaining reputed company and high ethical standards. • Position may require occasional travel • Physical Requirements Office Setting - Must possess mobility to work in a reputed company office setting and use reputed company office equipment, including a reputed company to read printed materials and a computer screen; and hearing and speech to communicate in person, before reputed company, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to reputed company, reputed company, and retrieve data using a computer keyboard, mouse, or calculator, and to operate reputed company office equipment. Positions in this classification occasionally bend, stoop, kneel, reputed company, push, and pull drawers reputed company and reputed company to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds. This role can be based at our reputed company, CA or Brisbane, CA location (preferred) or can be remote based. reputed company is an equal opportunity employer. Apply tot his job Apply To this Job