TMF Operations Associate I

Worldwide Clinical Trials; Mexico; On-site; PHP 2,737,000 - 4,258,000; Full time

Job summary

Worldwide Clinical Trials is seeking a TMF Operations professional to support Trial Master File processes. The role focuses on approving TMF documents, classifying records and ensuring adherence to SOPs across studies.

You'll work with multiple TMF systems, collaborate with the RMC Lead, and help maintain accurate files while supporting the TMF team in a highly regulated CRO environment.

Qualifications

• Possess data collection, indexing and editing skills with disciplined naming conventions.
• Excellent written and verbal communication to clearly present information.
• Able to work with internal teams under general direction and seek help as needed.
• Demonstrate sound judgment and identify decisions requiring supervisory approval.
• Proficient in Microsoft Word and Excel.
• Develop proficiency in use of an electronic document repository or eTMF and document recognition.

Responsibilities

• Fulfil the TMF Approver role per SOPs and practices.
• Review, process and resolve rejected TMF documents across studies.
• Work with Electronic Document Management and eTMF systems to classify documents.
• Communicate with RMC Lead to report TMF trends and issues.
• Escalate TMF quality issues promptly to RMC Lead.
• Provide admin support for RMC Lead including filing and trackers on study SharePoint.
• Perform additional tasks as assigned by Line Manager.

Skills

Data collection

Indexing

Editing

Written and verbal communication

Team collaboration

Judgment

Microsoft Word

Microsoft Excel

eTMF systems

Education

University Degree

Tools

eTMF

Job description

Worldwide Clinical Trials is seeking a TMF Operations professional to support Trial Master File processes. The role focuses on approving TMF documents, classifying records and ensuring adherence to SOPs across studies.

You'll work with multiple TMF systems, collaborate with the RMC Lead, and help maintain accurate files while supporting the TMF team in a highly regulated CRO environment.