eTMF & Trial Master File Expert

Parexel; Canada; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading clinical research organization in Canada is seeking a Trial Master Files Records Specialist. The role involves providing operational expertise to manage trial records, ensuring compliance with regulations, and supporting trial teams. Ideal candidates should have excellent organizational and communication skills, experience in clinical operations, and knowledge of eTMF systems. This role is full-time and requires a high school diploma with a preference for further education in business administration.

Qualifications

• Experience in Clinical Operations preferred.
• Excellent knowledge in use of eTMF systems.
• Advanced knowledge of ICH-GCP and Good Documentation Practice.

Responsibilities

• Provide operational expertise to the core trial team.
• Oversee implementation of the TMF strategy for the trial.
• Maintain oversight of TMF activities throughout the trial.

Skills

Excellent organizational and communication skills

Structured mindset for administrative tasks

Excellent time management

Commitment to results and problem solving

Proficiency with Windows MS Office

Proficiency in written and spoken English

Education

High School Diploma

Post Secondary education in Business Administration

Tools

eTMF systems

Job description

A leading clinical research organization in Canada is seeking a Trial Master Files Records Specialist. The role involves providing operational expertise to manage trial records, ensuring compliance with regulations, and supporting trial teams. Ideal candidates should have excellent organizational and communication skills, experience in clinical operations, and knowledge of eTMF systems. This role is full-time and requires a high school diploma with a preference for further education in business administration.