TMF Associate

SolCur; Town of Belgium (WI); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Telework options

Flexible working hours

32 days of holiday

Full electric company car

Health insurance

Lunch vouchers

Job summary

SolCur is seeking a TMF Associate in Wisconsin to support the maintenance and quality of the Trial Master File (TMF) for clinical studies. This role involves collaborating with various departments to ensure accurate and timely filing of documentation.

The ideal candidate holds a Bachelor’s degree in a relevant field, has experience with TMF management, and demonstrates strong organizational and communication skills. We offer a competitive salary and numerous employee benefits.

Qualifications

• Experience in clinical research, document management, or TMF management is preferred.
• Familiarity with ICH-GCP guidelines and clinical trial processes.
• Strong commitment to document quality and accuracy.

Responsibilities

• Maintain and support the Trial Master File (TMF) for clinical studies.
• Ensure timely filing and quality review of essential study documents.
• Monitor TMF health metrics and resolve documentation gaps.
• Assist in preparation for audits and inspections.
• Support the development and improvement of TMF processes.

Skills

Attention to detail

Organizational skills

Communication skills

Collaboration skills

Education

Bachelor’s degree in Life Sciences or related field

Tools

Microsoft Office

eTMF systems

Job description

The TMF Associate is responsible for supporting the maintenance, quality, and completeness of the Trial Master File (TMF) throughout the lifecycle of clinical studies. This role works closely with Clinical Operations, Study Management, Regulatory Affairs, Quality Assurance, and external partners to ensure that all essential clinical trial documentation is filed accurately, timely, and in compliance with applicable regulatory requirements, industry standards, and internal procedures. The TMF Associate plays a key role in maintaining inspection readiness and supporting the overall quality and integrity of clinical trial documentation.

Main activities are:

• Maintain and support the electronic and/or paper Trial Master File (TMF) for one or more clinical studies.
• Ensure timely filing, indexing, classification, and quality review of essential study documents throughout the study lifecycle.
• Perform routine TMF quality control activities to verify completeness, accuracy, consistency, and compliance with TMF standards.
• Monitor TMF health metrics and identify missing, incomplete, overdue, or incorrectly filed documents.
• Follow up with study teams, functional departments, and external vendors to obtain and resolve TMF documentation gaps.
• Support ongoing TMF reconciliation activities with internal stakeholders and external service providers.
• Contribute to maintaining inspection-ready TMFs at all stages of clinical trial conduct.
• Assist in the preparation and support of internal audits, regulatory inspections, and TMF reviews.
• Ensure compliance with applicable regulations, ICH-GCP guidelines, TMF reference models, and company procedures.
• Collaborate with Clinical Operations, Regulatory Affairs, Data Management, Quality Assurance, and other functions to ensure proper document management practices.
• Support study start-up, conduct, and close-out activities from a TMF perspective.
• Participate in TMF migration, archival, and document transfer activities when required.
• Generate and maintain TMF tracking reports, dashboards, and status updates.
• Support the development and continuous improvement of TMF processes, tools, and best practices.
• Assist in training study teams and functional contributors on TMF requirements and document management standards.
• Escalate quality concerns, compliance risks, and documentation issues in a timely manner.

Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Sciences, Healthcare, Business Administration, or a related field.
• Experience in clinical research, document management, Trial Master File management, or a related area is preferred.
• Familiarity with clinical trial processes and applicable regulations, including ICH-GCP.
• Knowledge of TMF principles, inspection readiness requirements, and TMF Reference Model concepts is considered an asset.
• Experience working with electronic TMF (eTMF) systems is preferred.
• Strong attention to detail and commitment to document quality and accuracy.
• Excellent organizational and time management skills.
• Ability to manage multiple priorities and work effectively in a deadline-driven environment.
• Strong communication and collaboration skills.
• Proficiency in Microsoft Office applications and document management systems.
• Excellent written and verbal communication skills in English.

What we offer:

• We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
• We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, …)
• Side activities will be organised regularly, to achieve a close collaboration within our team
• We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
• We contribute to a number of charities & support the research and / or the patients in our industry.