TMF Coordinator

Alimentiv; Salvador; Teletrabalho; BRL 50 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Bonus

Resumo da oferta

Alimentiv is seeking a detail-oriented TMF Coordinator to join our TMF Operations team. You will maintain the quality, completeness, and regulatory compliance of trial master file documentation, ensuring inspection readiness and support for cross-functional trial execution.

Responsibilities include filing and indexing documents, applying ALCOA+ data integrity, coordinating with study teams, and performing QC checks to sustain TMF health and audit readiness. Remote work option available.

Qualificações

• 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

Responsabilidades

• Maintain TMF oversight and ensure compliance with regulatory requirements and ALCOA+ principles.
• File, classify, and index TMF documents; ensure version control and naming conventions.
• Utilize eTMF systems (Veeva Vault, Phlexglobal, Trial Interactive) for TMF management.
• Perform QC checks on TMF documents and metadata to ensure accuracy and timeliness.
• Support audit readiness, TMF health checks, and reporting metrics.
• Collaborate with study teams and stakeholders to address gaps and improvements.

Conhecimentos

Attention to detail

Organizational skills

Communication

Analytical thinking

Formação académica

Bachelor’s degree in Life Sciences or related field

Ferramentas

eTMF platforms (Veeva Vault, Phlexglobal, Trial Interactive)

Microsoft Office (Excel, Word, SharePoint)

Descrição da oferta de emprego

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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

+ bonus