Coordonnateur(trice) de la documentation TMF II/TMF Document Coordinator II

Job summary

The TMF Document Coordinator II manages and performs quality control on clinical trial documentation to ensure compliance with regulatory standards and study-specific guidelines. They also independently lead TMF activities for Investigator-Initiated Studies and smaller sponsored projects, including oversight of the eTMF from start to closeout.

Job details

The TMF Document Coordinator II manages and performs quality control on clinical trial documentation to ensure compliance with regulatory standards and study-specific guidelines. They also independently lead TMF activities for Investigator-Initiated Studies and smaller sponsored projects, including oversight of the eTMF from start to closeout. Candidates must hold a college degree and have at least one year of experience in clinical research within the biotech, pharmaceutical, or CRO industry. Proficiency in English, knowledge of TMF Reference Models, and strong computer skills in Microsoft Office are required.

What you’ll do

The TMF Document Coordinator II manages and performs quality control on clinical trial documentation to ensure compliance with regulatory standards and study-specific guidelines. They also independently lead TMF activities for Investigator-Initiated Studies and smaller sponsored projects, including oversight of the eTMF from start to closeout.

Requirements

Candidates must hold a college degree and have at least one year of experience in clinical research within the biotech, pharmaceutical, or CRO industry. Proficiency in English, knowledge of TMF Reference Models, and strong computer skills in Microsoft Office are required.

Benefits

• Flexible work schedule
• Permanent full-time position
• Company benefits package
• Ongoing learning and development
• Medical care
• Dental care
• Vision care
• RRSP
• Vacation
• Personal days
• Virtual medical clinic
• Public transit discount
• Social activities

Listed skills

• Quality Control · Preferred
• Regulatory Compliance · Preferred
• Project Coordination · Preferred
• Microsoft Word · Preferred
• Microsoft Excel · Preferred
• Attention to detail · Preferred
• Communication Skills · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical research
• TMF management
• Quality control
• Regulatory compliance
• ICH-GCP
• eTMF technologies
• Metadata classification
• Document management
• Project coordination
• Data reporting
• Microsoft Word
• Microsoft Excel
• Organizational skills
• Attention to detail
• Communication skills
• Health Canada regulations

Job areas

• Healthcare
• Science & Research
• Administrative

More jobs from Indero (formerly Innovaderm)