TMF Lead II

Premier Research

. Perform electronic and/or paper Trial Master File records management activities .

Posted 10/30/2026full-timeRemote • Argentina, United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Trial Master File (TMF) management, including eTMF systems, TMF Reference Model, and compliance with ICH-GCP and FDA regulations. Proven ability to lead TMF activities, provide training, and ensure audit readiness through effective oversight and quality management.

Highest-signal resume keywords

8+ Years eTMF Systems Experience8+ Years Trial Master File Management Experience8+ Years TMF Reference Model Experience2+ Years TMF Lead ExperienceKnowledge of ICH-GCP, ISO14155, FDA CFR Part 11

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Trial Master File ManagementETMF Systems ManagementTMF Quality OversightTMF Transition PlanningKPI Analysis and ReportingTMF Audit ParticipationTMF Process TrainingRecords ManagementChange-Order IdentificationTMF Status Updates

Soft Skills

LeadershipCommunicationTrainingCollaborationProblem-Solving

Industry Keywords

Clinical TrialsInvestigational Drug IndustryRegulatory ComplianceAudit ReadinessRecords and Information Management

About the role

Key responsibilities & impact

Perform electronic and/or paper Trial Master File records management activities
Lead the set-up, maintenance and closure of TMFs, including development and ownership of study TMF Plans and indexes
Perform TMF Transitions and use Sponsor TMF processes and systems
Provide oversight, training, KPI analysis and reporting of TMF status
Identify and address TMF quality and completeness deficiencies affecting audit and inspection readiness
Act as primary TMF point of contact for project teams, Sponsors, auditors and other third parties
Work directly with records specialists assigned to studies
Work with the eTMF Administrator to resolve system-related issues
Review TMF scope of work and identify out-of-scope activities for change-order consideration
Provide regular TMF status updates to Project Leadership and Functions
Assist with monitoring security, environment and access control of Secure File Room facilities
Monitor compliance with TMF SOPs and TMF Plans
Perform live, web-based and recorded TMF process and systems training
Perform departmental budgeted activities for assigned studies
Develop, sign and maintain TMF Plans, TMF Transition Plans and indexes
Participate in TMF audits and inspections as TMF representative
Coordinate project team quality reviews of TMFs

Requirements

What you’ll need

Minimum of a high school diploma or international equivalent required
Undergraduate degree preferred from an accredited institution majoring in records and information management, library science, clinical, science or health related field
Equivalent level of clinical trials records management experience accepted as an alternative to the preferred undergraduate degree
8+ years eTMF systems experience required
8+ years of Trial Master File management experience required
8+ years TMF Reference Model experience required
2+ years TMF Lead experience required
Knowledge of ICH-GCP, ISO14155, FDA CFR Part 11 and global regulations related to the investigational drug and device industry required

Benefits

Comp & perks

Flexibility and balance to support your life
Skills and opportunities for professional growth and career development