Senior Essential Document Specialist – Remote

Job DescriptionThe Senior EDS will serve as a liaison between the EDS team and the EDL Lead/EDM. They support strategies, procedures and tools for the optimization of EDM processes. In addition to performing tasks of the Essential Document Specialist (shown below), the Senior EDS will also be responsible for onboarding new EDS employees as well as coordinating, leading and execution of EDS tasks as well as additional tasks to support EDS operations while acting as a Subject Matter Expert (SME).Essential Document Specialist ResponsibilitiesSupport Essential Document Le and ManagerSupport strategies, procedures, and tools for the optimization of the processes.Applies creative solutions to complex site ready situations and demonstrates situational leadership within cross functional teams.Interact with external partners for programmatic and functional sourcing.Recognizes and considers various solutions to problems or situations.Execution: Works with internal/external partners to assure document processing times are maintained; Monitors/tracks compliance of study essential documents; Ensures the integrity of the essential clinical trial documents (both hardcopy and electronic) within the Official Regulatory files.Internal/External Interactions: Ensures proper communication with external partners, stakeholders, and customers; Liaises with clinical teams and external partners to achieve site ready timelines; Interfaces with staff members to provide support and guidance.Performance Tracking: Identifies and reviews metrics to assure process remains efficient and effective audit and Inspection Support: Works with inspection support teams to ensure inspection process readiness.Assists in retrieval of documentation during sponsor inspections.Supports the development of responses to audits and inspections and ensures appropriate implementation.Ensures that all actions and commitments are implemented in a timely manner.Education RequirementsBachelor’s degree required.Computer SkillsIntermediate level in Adobe Acrobat including knowing how to edit, extract and redact pagesMicrosoft Office Suite 2010 or higherBeginner to Intermediate experience level in WORDIntermediate experience level in EXCELIntermediate experience level in OutlookExperienceA minimum of 3 years as an Essential Document Specialist and at least 5 years of relevant experience in clinical research.General knowledge of ICH-GCP and other relevant regulations pertaining to essential documents.Must have intermediate understanding of the functional area responsibilities associated with the clinical development process, trial management, and clinical trial management systems, as well as quality management and control tools.Required SkillsAdaptabilityClinical DocumentationClinical Site ManagementClinical Trial ComplianceClinical Trial DocumentationClinical Trial Management ProcessesClinical Trial PlanningClinical TrialsClinical Trials MonitoringClinical Trials OperationsCross-Cultural AwarenessICH GCP GuidelinesInspection ReadinessPerformance TrackingProcess OptimizationUS and Puerto Rico Residents Only.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.Salary range: $117,000.00 – $184,200.00.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.Employee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: RemoteShift: 1st – DayValid Driving License: NoHazardous Material(s): NoJob Posting End Date: 05/23/2026Requisition ID: R395087#J-18808-Ljbffr