Remote TMF Quality Review Associate – Mexico

ICON Strategic Solutions; México; Remote; MXN 500,000 - 900,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance options

Retirement planning

Job summary

ICON Strategic Solutions is hiring for a Home Based TMF Manager in Mexico. You will take responsibility for TMF documentation, ensuring completeness and regulatory compliance across trial lifecycles.

You will partner with cross-functional teams to gather and maintain essential documents for regulatory submissions. Qualified candidates bring 3+ years in clinical research or document management, a life sciences degree, and strong attention to detail with excellent communication skills.

Qualifications

• Minimum 3 years of experience in clinical research or document management.
• Bachelor's degree in life sciences or related discipline is required.
• Strong attention to detail and ability to manage multiple tasks concurrently.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Manage Trial Master File (TMF) documentation in line with client requirements and ICON procedures.
• Ensure completeness, accuracy, and timeliness of TMF documents throughout trial lifecycles.
• Collaborate with cross-functional teams to collect, review, and maintain essential documents for regulatory submissions.
• Conduct quality checks and audits of TMF documents to ensure regulatory compliance.
• Provide guidance to internal and external stakeholders on TMF-related matters.

Skills

Attention to detail

Organizational skills

Communication skills

Cross-functional collaboration

Travel willingness

Education

Bachelor's degree in life sciences

Bachelor's degree in a related field

Job description

ICON Strategic Solutions is hiring for a Home Based TMF Manager in Mexico. You will take responsibility for TMF documentation, ensuring completeness and regulatory compliance across trial lifecycles.

You will partner with cross-functional teams to gather and maintain essential documents for regulatory submissions. Qualified candidates bring 3+ years in clinical research or document management, a life sciences degree, and strong attention to detail with excellent communication skills.