Associate Trial Master File Specialist

United States - Remote

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 Associate Trial Master File (TMF) Specialist will provide support for Trial Master File activities to global clinical study teams. This role will be responsible for performing data entry for site, country, and study level documents, and day-to-day support of TMF activities, which may include quality control (QC) and quality review of clinical documents, training on clinical document management and TMF business processes and the eTMF system, Veeva Vault.

Responsibilities

• Perform 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.)
• Ensure the TMF file structure follows applicable company approved TMF configuration, 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
• Ensure customer requests for retrieval, reproduction, and refiling of requested records or electronic images (e.g., PDF, jpeg) are met in a timely manner
• Classify and add metadata to uploaded documents in eTMF (Site level documents uploaded by iCRA, Country level documents uploaded by SME, and Study/Trial level documents uploaded by SME); may upload documents as required
• Identify trends/patterns in quality issues for training purposes
• Assist with activities for transfer, delivery, and off-site archival of TMF records where requested by sponsor
• May assist with audit/inspection preparation
• May assist with reviewing updates to project TMF Plans, Filing Guidance's, and Work Instructions
• May assist in site activation and maintenance activities, including collecting and reviewing essential documents from clinical sites.
• Other duties as assigned

Experience

• Bachelor's Degree (scientific discipline preferred) or equivalent preferred
• 1-year or more prior Trial Master File experience preferred, but not required
• Knowledge of clinical research concepts is helpful
• Ability to access technical information and read study materials such as protocols, MOPs, and User Guides, and understand the overall purpose and objectives of the documents
• Excellent organizational and planning skills, including strong attention to detail
• Ability to build and maintain positive relationships with management and peers and able to work in a team environment
• Excellent written and verbal skills required
• Displays strong analytical and problem-solving skills
• Applies knowledge learned from one task to the next
• Brings QC observations to the attention of project staff
• Exercises judgment within defined procedures and practices to determine appropriate action

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Unlimited Approved Leave

• Tuition Reimbursement

• 401k & Profit Sharing Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.