TMF Coordinator

Alimentiv; Poland; Hybrid; PLN 158,000 - 263,000; Full time

Benefits offered by this job

Bonus

Job summary

Alimentiv is seeking a detail-oriented TMF Coordinator to join the TMF Operations team. You will maintain the quality, completeness, and compliance of Trial Master File documentation across global regulatory standards to support inspection readiness and trial execution.

You will file and index documents in eTMF systems (Veeva Vault, Phlexglobal, Trial Interactive), apply ALCOA+ data integrity, and collaborate with cross-functional stakeholders to ensure timely, accurate TMF content.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 1–3 years 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.

Responsibilities

• Maintain TMF structures and ensure compliance with ICH-GCP, FDA, EMA.
• File, classify, and index documents in the TMF with version control.
• Perform TMF QC checks and resolve missing or inconsistent records.
• Support inspection readiness, audits, and health checks.
• Collaborate with study teams to gather documentation and guide TMF requirements.

Skills

TMF management

Regulatory compliance

Documentation management

Quality checks

Remote collaboration

Education

Bachelor’s degree in Life Sciences or related field

Tools

Veeva Vault

Phlexglobal

Trial Interactive

Excel

SharePoint

Job description

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.

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 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

$42,000 - $70,000 a year

+ bonus