Senior Essential Document Specialist - Remote

Merck • North Wales, PA

2d • $117,000 - $184,200 • Remote

About The Position

The 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).

Requirements

• Bachelor’s degree required.
• Intermediate level in Adobe Acrobat including knowing how to edit, extract and redact pages
• Microsoft Office Suite 2010 or higher
• Beginner to Intermediate experience level in WORD
• Intermediate experience level in EXCEL
• Intermediate experience level in Outlook
• A minimum of 3 years as an Essential Document Specialist
• 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.
• Adaptability
• Clinical Documentation
• Clinical Site Management
• Clinical Trial Compliance
• Clinical Trial Documentation
• Clinical Trial Management Processes
• Clinical Trial Planning
• Clinical Trials
• Clinical Trials Monitoring
• Clinical Trials Operations
• Cross-Cultural Awareness
• ICH GCP Guidelines
• Inspection Readiness
• Performance Tracking
• Process Optimization

Responsibilities

• Support Essential Document Leads and Manager
• Support 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.
• Onboarding new EDS employees.
• Coordinating, leading and execution of EDS tasks.
• Performing additional tasks to support EDS operations.
• Acting as a Subject Matter Expert (SME).

Benefits

• medical
• dental
• vision healthcare
• other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior