Support Trial Master File (TMF) activities to ensure TMFs are “inspection ready” throughout study lifecycle and TMF documents are filed contemporaneously. Primarily responsible for document attribute review, processing, tracking, and filing; and paper and/or electronic folder creation. Serve as the main contact for the secure file room. Work proactively and successfully within a cross-functional team. Embody 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

• Receive, log and track study documentation in TMF system(s) while identifying defective documents.
• Process and review documents, following applicable scanning and coding procedures and best practices, and applying ALCOA principles appropriately.
• File and retrieve TMF documents in a timely manner.
• Prepare paper and electronic folders in accordance with established TMF folder structures.
• Understand priorities and timelines to plan day-to-day workload.
• Draw on knowledge to address inquiries, escalating as needed.
• Assist with activities in preparing TMF for audits, file reviews and transfers.
• Perform other study TMF-related tasks as required by the study teams and/or senior leadership.

Department Support

• Complete routine administrative tasks in a timely manner.
• Maintain department specific office supplies.
• Perform activities related to the secure file room.
• Assist with the planning and execution of in-house archiving and in the organization and filing of clinical and corporate records.
• Share ideas for the improvement of processes and systems to help with the efficient operations of the department.

Qualifications

• The successful candidate will posses a post secondary education certificate with 1-3 years of relative experience.
• The ability to be in office 1-2 times per week.
• Demonstrated ability to adapt to changes in a fast-paced environment. Adjust priorities due to fluctuating workload demands with minimal supervision. Good interpersonal skills to build and maintain relationships. Demonstrated computer literacy, proven functional knowledge of Microsoft packages and potential to develop.