TMF Associate

This range is provided by Alimentiv. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

CA$52,500.00 / yr - CA$87,500.00 / yr

Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study setup to transfer / archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to the TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. Time allocated may be adjusted based on need.

Service Delivery

• Serve as the primary TMF contact for assigned studies
• Ensure TMF is complete and “inspection ready” throughout study lifecycle and documents are filed contemporaneously
• Work with Team Lead to create study specific TMF management and oversight documents (e.g., File Index, Expected Document Lists and TMF Management Plan) in alignment with study
• Develop and maintain study-specific work instructions, as needed
• Utilize organization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness
• Review and communicate out-of-scope and / or incomplete documents to study teams; escalating as needed
• Reconcile expected document lists based on study events and milestones
• Prioritize and resolve TMF help desk tickets; may include triaging activities
• Provide study specific TMF training to internal and / or external stakeholders, as needed
• Process and review documents, following applicable scanning and best practices and best practices, and applying ALCOA principles appropriately
• File and retrieve TMF documents in a timely manner

Department Support

Qualifications

Working Conditions

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Seniority level

Employment type

Job function

Industries

Referrals increase your chances of interviewing at Alimentiv by 2x

Get notified about new Associate jobs in Kitchener, Ontario, Canada .

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr