Dexian · 2 days ago
TMF Specialist
Bethesda, MD
Contract
Hybrid
New Grad, Entry, Mid, Senior Level
$30/hr - $40/hr
0+ years expDexian is a leading provider of staffing, IT, and workforce solutions. The TMF Specialist is responsible for the set-up, maintenance, quality control, and inspection readiness of the Trial Master File (TMF) across clinical studies, ensuring compliance with regulatory requirements and supporting cross-functional teams.
ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency
Hiring Manager
Jaydeep Gajjar
Responsibilities
Own TMF set-up, ongoing maintenance, quality management, and inspection readiness activities across assigned clinical studies
Ensure TMF documentation complies with eTMF specifications, ICH/GCP guidelines, regulatory requirements, and internal SOPs
Perform TMF quality control (QC) and quality assurance (QA) reviews to ensure completeness, timeliness, and accuracy of documents
Manage TMF tracking, metrics, dashboards, and reporting for internal and external stakeholders
Coordinate cross-functional document collection, filing, reconciliation, and remediation activities
Support audit and inspection readiness, including document retrieval and response support for regulatory inspections
Serve as the primary liaison between TMF records management, project teams, vendors, and external clients
Manage client and internal requests for TMF document retrieval, reproduction, and re-filing within agreed timelines
Maintain up-to-date knowledge of the TMF Reference Model, regulatory guidance, and industry best practices
Assist with development and maintenance of TMF SOPs, work instructions, training materials, and governance documentation
Train, mentor, and support TMF staff and project team members on TMF processes and best practices
Monitor daily TMF activities to ensure project deadlines, commitments, and quality standards are met
Support study close-out activities, including preparation and transfer of TMF records to final archival destinations
May support task management, project oversight, or line management responsibilities based on experience level
Qualification
Required
Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical documentation and TMF management
Solid understanding of clinical research processes and trial documentation lifecycle
Exceptional attention to detail with strong organizational and analytical skills
Ability to manage multiple priorities in a fast-paced, deadline-driven environment
Proven ability to identify TMF risks and proactively resolve quality or compliance issues
Excellent written and verbal communication skills with internal and external stakeholders
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Bachelor's degree (B.A./B.S.) in a science or healthcare-related field required
Preferred
Hands-on experience working in eTMF systems; Veeva Vault or Trial Interactive strongly preferred
TMF Specialist Level I (0–2 years): Entry-level TMF professional with hands-on TMF review experience and foundational knowledge of FDA, ICH, and EMA requirements
TMF Specialist Level II (2–4 years): Experienced TMF professional with oversight of TMF completeness, timeliness, and accuracy; experience mentoring junior staff and supporting TMF plans and indexes
TMF Specialist Level III (4+ years): Senior-level TMF SME with oversight of multiple studies, deep regulatory expertise, independent development of TMF Plans and Indexes, and leadership or line management experience
Detail-driven, proactive, and inspection-focused mindset
Strong collaborator who can effectively partner with Clinical Operations, QA, Regulatory, and external vendors
Comfortable serving as a trusted TMF advisor to project teams and leadership
Company
Dexian
Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.
1001-5000 employees
H1B Sponsorship
Dexian has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (65)
Funding
Current Stage
Late StageLeadership Team
Mahfuz Ahmed
Chairman of the Board
Vikram Motiani
Managing Director
Recent News
2025-11-19
Company data provided by crunchbase