TMF Coordinator

Résumé du poste

The TMF Coordinator is responsible for maintaining the quality, completeness, and compliance of Trial Master File documentation in accordance with global regulatory standards. They will perform quality control checks, manage document indexing, and collaborate with cross-functional teams to ensure inspection readiness.

Détails du poste

We are seeking a detail-oriented and highly organized TMF Coordinator to join our TMF Operations team. In this role, you will be responsible for maintaining the quality, completeness, and compliance of Trial Master File (TMF) documentation in alignment with global regulatory requirements and company standards. You will play a key role in ensuring that TMF content remains inspection-ready and supports clinical trial execution through effective document management and collaboration with cross-functional stakeholders. Positions Available: 2; Note this position is cross-listed in multiple countries. \n TMF Oversight & Compliance * Maintain in-depth knowledge of TMF structures (paper and electronic) * Ensure compliance with ICH-GCP, FDA, and EMA regulations * Apply ALCOA+ data integrity principles * Support inspection readiness and audit activities * Ensure proper management of essential clinical trial documentation Systems & Document Management * Accurately file, classify, and index documents within the TMF * Ensure adherence to version control and naming conventions * Utilize eTMF systems (e.g., Veeva Vault, Phlexglobal, Trial Interactive) * Maintain consistency and compliance of TMF structure * Demonstrate proficiency in eTMF and document management systems * Utilize Microsoft Office tools (Excel, Word, SharePoint) for reporting and coordination Quality Control * Perform QC checks on TMF documents and metadata * Identify and resolve missing, incomplete, or inconsistent records * Ensure overall accuracy, completeness, and timeliness of TMF content * Support TMF health checks and reporting metrics Issue Resolution & Continuous Improvement * Investigate and resolve TMF gaps and discrepancies * Troubleshoot filing and system-related issues * Contribute to process improvements and standardization initiatives * Support root cause analysis for quality issues Stakeholder Engagement * Collaborate with study teams and Proactively follow up on outstanding documentation * Provide clear guidance on TMF requirements and processes * Support audit and inspection readiness activities Required Qualifications & Experience * Bachelor’s degree in Life Sciences or a related field (preferred) * 1-3 years direct full-time experience in clinical trials TMF management * Working knowledge of eTMF platforms and regulatory requirements * Strong understanding of clinical trial record management and quality standards * Working remotely Core Competencies * Strong attention to detail and quality focus * Excellent organizational and time management skills * Effective communication and stakeholder engagement * Analytical thinking and problem-solving ability * Ability to manage multiple priorities in a fast-paced environment \n $42,000 - $70,000 a year + bonus \n

Ce que vous ferez

The TMF Coordinator is responsible for maintaining the quality, completeness, and compliance of Trial Master File documentation in accordance with global regulatory standards. They will perform quality control checks, manage document indexing, and collaborate with cross-functional teams to ensure inspection readiness.

Exigences

Candidates should possess a Bachelor's degree in Life Sciences and 1-3 years of experience in clinical trial TMF management. Proficiency in eTMF platforms and a strong understanding of regulatory requirements such as ICH-GCP, FDA, and EMA are essential.

Avantages

• Bonus

Compétences indiquées

• Regulatory Compliance · Souhaitée
• Quality Control · Souhaitée
• Root Cause Analysis · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• TMF Management
• Clinical Trials
• Regulatory Compliance
• ICH-GCP
• FDA Regulations
• EMA Regulations
• ALCOA+ Principles
• eTMF Systems
• Veeva Vault
• Phlexglobal
• Trial Interactive
• Document Management
• Quality Control
• Data Integrity
• Stakeholder Engagement
• Root Cause Analysis
• Veeva
• Analytical Thinking
• Effective Communication
• Auditing
• Management
• Version Control
• Continuous Improvement Process
• Document Management Systems
• Good Clinical Practices (GCP)
• Problem Solving
• Life Sciences
• Metadata
• Microsoft Office
• Operations
• Quality Management
• Telecommuting
• Microsoft SharePoint
• Time Management
• Trial Master File
• Troubleshooting (Problem Solving)
• Naming Conventions
• Process Improvement
• Coordinating
• Filing
• Detail Oriented

Domaines d’emploi

• Healthcare
• Science & Research
• Administrative
• TMF Specialist
• Document Control / Management Specialist
• Filing and Copying Clerks
• Document Management Specialists
• Computer Occupations, All Other