Senior TMF Associate (Canada)

The Senior TMF Associate is the Subject Matter Expert (SME) for the product line Trial Master Files (TMFs), ensuring all TMFs meet departmental standards of quality, completeness, and timeliness. This role is pivotal in maintaining high standards and continuous improvement in TMF management.

Training, Mentoring and Onboarding (10-15%)

• Provide ongoing mentoring and training to TMF Coordinators (TMFCs) and TMF Associates (TMFAs) within the product line to ensure consistent performance in accordance with internal and industry standards.
• Onboard and train new team members in the product line.
• Collaborate with the Quality Training Compliance (QTC) to enhance current training and onboarding processes.

Product line TMF Delivery (50-55%)

• Utilize available metrics to ensure product line TMFs meet departmental standards of quality, completeness and timeliness.
• Identify trends in quality, completeness, and timeliness within the product line, highlighting areas for improvement or additional training.
• Ensure TMFCs are meeting document processing and timelines.
• Ensure TMFAs send oversight reports at least each quarter.
• Act as a SME for product line TMF management plans, file indices and TMF processes.
• Collaborate with TMFAs and TMFCs during product line audits, to ensure the TMF is audit ready.

Individual TMF Delivery (20-25%)

• Manage TMFs for assigned studies from start-up to close-out and transfer.

Process Improvement (20-25-%)

• Collaborate with TMFO and other internal stakeholders to develop, optimize and maintain TMF processes and Quality systems documents.
• Acts as SME and/or process owner for TMFO quality system documents.
• Owns and leads straightforward Quality System process improvement and updates. Developing new or updating current quality system documents (SOPs, WIs, templates etc.). Has input and collaborates on more complex Quality system process improvements and updates.
• Collaborates to improve product line quality, completeness and timeliness.

Qualifications

• 4 - 6 years of related experience
• (Honors) Bachelor’s degree
• Fluent in reading, writing and speaking in English
• Deep understanding of GCP, GDP and ALCOA++.
• Working knowledge of TMF reference model file index and TMF management plan.
• Proven experience working in TMF operations at a CRO and/or Sponsor organization.

$69,000 - $92,500 a year

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