Job Description

Overview:

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee -- from entry level through top executive -- to contribute to our clients' success by sharing ideas openly and honestly. Primary Purpose

The Trial Master File (TMF) Specialist is responsible for the overall management, quality, and maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the TMF, with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/TMF guidelines. This position plays a key role in both paper and electronic global TMF system management, by filing, organizing, and maintainingpaper and/or digital records and coordinating the document management activities performed by third parties, such as vendors, clinical sites, collaborators, as well as other internal and external team members, as required.
Responsibilities:
• Performs key TMF Specialist duties in accordance with the company guidelines and work instructions (e.g., TMF set-up, quality management reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.)
• Accountable for the overall TMF quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, including third party documents and TMF tracking and reporting to internal and external customers
• Ensures the TMF file structure follows applicable company approved TMFconfiguration, regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model
• Ensures that all new and updated record information is accurately entered in the appropriate records management databases, and is maintained in accordance with the company eTMF and/or other electronic data room storage SOPs, processes, and data structure for inspection readiness under minimum supervision
• Ensures customer requests for TMF retrieval, reproduction, and re-filing of requested records or electronic images (e.g. PDF, jpeg) are met in a timely manner
• Classify and add metadata to uploaded document (Site Level docs uploaded by iCRA, Country level docs uploaded by SME, and Study/Trial level docs uploaded by SME); may upload documents as required
• QC review and approve documents to ensure that all new and updated documents are accurately entered in the appropriate records management databases for inspection readiness
• Proactively assists project staff in tracking that essential documents are received and maintained across assigned studies and sites; may interface directly with sites to complete all document collections and check for accuracy
• Assists with the development and maintenance of the company's digital records/TMF training materials, SOPs, and guidelines and may perform trainingand/or coaching of new and existing staff as required under supervision
• May run project specific metrics, identifies trends, risks, and associated actions for assigned projects
• Assists with activities for transfer, delivery, and off-site archival of TMF records under minimal supervision
• May assist with audit/inspection preparation
• May assist with reviewing updates to project TMF Plans, Filing Guidance, and Work Instructions
• May assist in site activation and maintenance activities, including collecting and reviewing essential documents from clinical sites
• May collaborate with project team to ensure all appropriate documents have been filed prior to specific study milestones (e.g., site activation, amendments, close-out and TMF delivery)
• May be responsible for tasks associated with posting studies to ClinicalTrials.gov
• Other duties as assigned

Qualifications:
• Bachelor's required, preferably in scientific discipline
• 2-3 years of experience in relevant document management preferred
• 1 year or more of experience with electronic Trial Master Files (eTMF) systems highly preferred, especially Veeva Vault
• Experience with coordinating document management activities performed by third parties, such as clinical vendor
• Knowledge of clinical research concepts
• Working knowledge of Good Clinical Practices (GCP) and TMF governing regulations, such as TMF Reference Model
• Thorough understanding of records management requirements in Drug Development
• Ability to access technical information and read study materials such as protocols, MOPs, and User Guides critically and identify areas of inconsistency and other quality issues and make recommendations for improvement
• Ability to build and maintain positive relationships with management, peers, and subordinates and able to work in a team environment
• Excellent organizational and planning skills, including strong attention to detail
• Excellent written and verbal skills required
• Display strong analytical and problem-solving skills
• Demonstrates capacity to synthesize information from one protocol/technical task to another on the same project
• May provide task specific mentorship to project staff

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