Join a dynamic team as a Trial Master File Associate, managing TMF content for study life cycles in a hybrid working environment. Ensure compliance and organization in TMFs while interacting with cross-functional teams.
This full-time TMF Associate role focuses on managing content from study setup to archiving. You'll work closely with study teams during audits, maintain an organized electronic file repository, and promote company practices. This position requires collaboration within a cross-functional team dynamic.
Key Responsibilities:
- Serve as primary TMF contact for studies
- Ensure TMF is inspection-ready throughout the lifecycle
- Develop study-specific TMF management documents
- Maintain quality control schedules for TMF completeness
- Provide training to internal and external stakeholders
Requirements:
- College diploma/degree and 1-3 years of experience
- Understanding of TMF organization and regulations
- Strong time management and problem-solving skills
- Proven Microsoft Office proficiency
- Ability to apply ALCOA principles effectively
Elevate your career in TMF operations with a focus on quality and compliance.
Trial Master File Associate in Ottawa employer: Alimentiv
At Alimentiv, we pride ourselves on being a purpose-driven employer that invests in our people and their professional growth. Our collaborative work culture fosters innovation and accountability, while our comprehensive benefits, including education reimbursement and mentorship programs, ensure that you feel valued and supported in your career journey. Join us in advancing therapies for gastrointestinal diseases and be part of a team that is dedicated to making a meaningful impact in the lives of patients worldwide.
