Associate II, TMF Operations

Jobgether; España; Presencial; EUR 28.000 - 40.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Exposure to international studies

Electronic TMF technologies

Career development opportunities

Collaborative global team

Descripción de la vacante

Jobgether in Spain is seeking an Associate II, TMF Operations to support accurate, compliant management of essential clinical trial documentation within a global CRO environment.

You will perform TMF QC and approval activities, index and maintain electronic and hard-copy records, prepare quality control checklists, and collaborate with project teams across regions to ensure inspection readiness and data integrity.

Formación

• University degree preferred, ideally in Life Sciences.
• Up to 1–2 years of TMF operations experience or related environment.
• General understanding of clinical trial principles and TMF purpose.
• Experience with electronic document repositories or eTMF platforms.

Responsabilidades

• Perform TMF Approver and/or TMF QC Reviewer activities per SOPs and established practices.
• Process, review, classify, and resolve rejected TMF documents across studies and sponsor portfolios.
• Manage essential documents in electronic and hard-copy formats with accuracy.
• Prepare periodic TMF Quality Control checklists and coordinate their review with project teams.
• Conduct TMF quality control activities to verify regulatory compliance and ICH GCP principles.
• Work with electronic document management systems to review, index, process, and maintain essential documentation.
• Apply standardized document naming conventions and indexing requirements for inspection readiness.
• Collaborate with project teams across geographies to resolve documentation issues.

Conocimientos

Attention to detail

Organization skills

Communication

Documentation

Team collaboration

Educación

University degree preferred

Life Sciences background

Herramientas

Microsoft Word

Microsoft Excel

eTMF systems

Descripción del empleo

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate II, TMF Operations based in Spain.

This role supports the accurate and compliant management of essential clinical trial documentation within a global Clinical Research Organization (CRO) environment.

You will help ensure Trial Master File (TMF) records are processed, reviewed, maintained, and archived according to established procedures and regulatory expectations.

The position combines document quality control, records management, and collaboration with international clinical project teams.

You will contribute directly to data integrity and inspection readiness across complex studies and sponsor portfolios.

The role offers exposure to electronic TMF and document management systems while developing your understanding of clinical research operations.

Success requires strong attention to detail, organization, and the ability to manage multiple deadline-driven activities with accuracy.

It is an excellent opportunity for an early-career professional seeking to build expertise in clinical documentation and TMF operations.

Accountabilities

• Perform TMF Approver and/or TMF QC Reviewer activities in accordance with applicable Standard Operating Procedures (SOPs) and established working practices.
• Process, review, classify, and resolve rejected Trial Master File documents across complex clinical studies and sponsor portfolios.
• Manage essential documents in both electronic and hard-copy formats while maintaining accurate records and consistent document standards.
• Prepare periodic TMF Quality Control checklists and coordinate their review with relevant project team members.
• Conduct periodic TMF quality control activities to verify compliance with regulatory requirements, ICH GCP principles, sponsor expectations, SOPs, and industry best practices.
• Work with electronic document management repositories and eTMF systems to review, index, process, and maintain essential clinical trial documentation.
• Apply standardized document naming conventions and indexing requirements to ensure records are complete, accurate, searchable, and inspection-ready.
• Collaborate regularly with project teams and colleagues across functions and geographies to resolve documentation issues and support efficient TMF processes.
• Maintain high standards of accuracy while managing multiple detailed activities within established timelines.

Requirements

• University degree preferred, ideally in Life Sciences or a related discipline.
• Up to 1–2 years of relevant experience in TMF operations, records management, clinical research, CRO, pharmaceutical, or a related environment.
• General understanding of clinical research principles, clinical trial processes, and the purpose of Trial Master Files.
• Experience or demonstrated ability in data collection, indexing, document editing, and applying standardized naming conventions.
• Ability to work effectively with electronic document repositories, eTMF platforms, or similar document management systems, with willingness to develop further technical proficiency.
• Strong written and verbal communication skills, with the ability to present information clearly, accurately, and concisely.
• Exceptional attention to detail and accuracy when handling highly structured and sensitive documentation.
• Strong planning, prioritization, and organizational skills, with the ability to manage multiple tasks in a deadline-driven environment.
• Proficiency with Microsoft Word and Excel.
• Strong interpersonal and collaboration skills, with the ability to work effectively in a fast-paced, changing, and globally distributed environment.
• A proactive, reliable, and quality-focused approach to work, with a commitment to following procedures and maintaining compliance.

Benefits

• Opportunity to build specialized experience in TMF operations and clinical research within a global CRO environment.
• Exposure to international clinical studies, sponsor portfolios, project teams, and industry best practices.
• Hands-on experience with electronic TMF and document management technologies.
• Opportunities to collaborate with experienced professionals across clinical research and project teams.
• A supportive and inclusive working environment that values collaboration, creativity, and professional development.
• Career development opportunities within a global organization focused on improving clinical research and patient outcomes.
• An environment committed to equal opportunity, diversity, inclusion, and respectful collaboration.
• Meaningful work contributing to the quality, compliance, and integrity of clinical trials that can ultimately improve patients' lives.