Senior Trial Master File (TMF) Specialist

US Remote Worker

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 Senior 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 maintaining paper 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 Senior 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 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 SOP's, processes, and data structure for inspection readiness under minimum supervision
• Ensures customer request for TMF retrieval, reproduction, and re-filng of requested records or electronic images (e.g. PDF, jpeg) are met in a timely manner
• SME for project staff on TMF related questions; determines methods and procedures for new assignments and provides guidance or supervision to other personnel and subcontractors, including the oversight of day-to-day activities
• Performs quality checks on junior staff's work and provides re-training to the project team, as necessary
• 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
• Leads project staff in tracking that essential documents are received and maintained across assigned studies and sites under minimal supervision
• Develops and maintains company's digital records/TMF training materials and guidelines and performs training and /or coaching of new and existing staff as required under minimal supervision
• Runs project specific metrics, identifies risks, escalates non-compliance and provides regular feedback to project teams including actionable metrics
• Provides project specific Veeva training for internal and external collaborators
• Manages activities for transfer, delivery and, off-site archival of TMF records as required by Sponsor
• May lead audit/inspection preparation with minimal supervision and participate in audits/inspections as required
• Leads review of project TMF plans, Filing Guidance, and Work Instructions, and company SOPs; suggests changes in project or corporate activities as appropriate and implements changes, as needed
• May assist in site activation and maintenance activities, including collecting and reviewing essential documents from clinical sites and provide guidance on document requirements as TMF SME
• Collaborates 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

Experience

• Bachelor's degree required, preferably in a scientific discipline
• Master's degree preferred
• 3-5 years or more of experience with electronic Trial Master Files (eTMF) solutions highly preferred
• Experience with coordinating document management activitites performed by third parties, such as clinical vendors
• Experience in mentoring less experienced Trial Master File staff
• Extensive knowledge of clinical research concepts and able to work in a team environment
• Awareness of Good Clinical Practices (GCP) and TMF governing regulations, such as TMF Reference Model
• Broad understanding of records management requirements in Drug Development
• Ability to access technical information and read study materials such as protocols, MOP's, 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
• Strong capacity to synthesize information from one protocol/technical task to another on the same project
• Mentor and role model for new personnel and may be involved in interviewing potential project staff

Emmes only requires all US new hires in the following job categories to be fully vaccinated before their first day of employment: (i) Clinical Research Associates (CRAs), (ii) Associate CRAs, and (iii) all CRA line managers. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

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 Retirement 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.