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1. Please review the Case Study and use all the provided information to consider how you would manage your workday and respond to the issues noted in the Case Study.
2. You should also be prepared to answer the questions listed at the end of the case study. You may be asked clarifying questions both during and after your presentation.
You are a TMF Study Owner based in the US. You have been assigned to a sponsor company who is a customer. This Pharmaceutical is a very large institution and can potentially bring many future opportunities to the company. The project is a significant initiative within the customer, and we are heavily supporting a large number of studies expected to be submitted for NDAs within the year.
There are several business-critical studies without a TMF specialist assigned and in the past year many have transitioned to a new operating model and migrated from the CROs eTMF to the Sponsor eTMF system. There are 8 functional leads within the sponsor study team that have new TMF responsibilities including eTMF access, document uploading and conducing an annual oversight QC of the TMF. This QC includes their functional documentation that demonstrates sponsor oversight of the trial and a risk-based portion of the TMF that is outsourced to the CRO. Each functional lead is expected to conduct the review, identify findings and work with their CRO counterpart to remediate them.
You will be working with these key members from cross-functional teams across Penn Pharmaceuticals to drive and oversee this activity. In your role, you will initiate the QC, train the study team members on the eTMF system and expectations and ensure that all the cycle is completed. You are also responsible for providing recurrent updates to the sponsor study team on the health and any risk areas to the TMF. As the TMF Study Owner, you serve as the main point of contact for the client and therefore you take full responsibility for QC kick off, oversight and completion status.
You also have 12 other assigned studies and while they are not currently due for the annual QC, these teams have questions, escalations and TMF health review meetings that you are expected to lead.
•Now that you are fully trained, you have received 12 new study assignments at various deliverable milestones. The client is under a very tight timeline to ensure that each study is meeting TMF expectations and remediate any noted deficiencies.
•You have been given 1 week to become familiar with your studies, their TMF health and identify suggested next steps prior to introducing yourself to the study teams. You have been provided with milestone tracking information, eTMF access and a folder for each study containing historical internal files for each of your studies. The client expects that after that time period you will schedule meetings with each of your Clinical Project Managers to introduce yourself, present the initial TMF gaps or findings based on your research and propose next steps for each study. You will also be expected to assess risk across the studies within your remit to prioritize competing deliverables.
•As you begin to dig in, you notice that study 96731 does not have a TMF Plan or TMF Index filed in the eTMF and that the study has reached 90 days post First Patient In, which is your milestone to trigger QC with the study team. Although the TMF governing documents are the responsibility of the CRO to complete and file, you understand that without the TMF Index, it will be very difficult for your study team to conduct the review. You also notice that 6 of the 8 sponsor study team members do not have access to the eTMF.
•This is your first opportunity to make a strong impression with your Line Manager and new study team members. While contemplating on how best to proceed you receive an email alerting you that another of your studies, 54139, is part of a larger program expected to be submitted to the FDA in 6 months as part of an NDA. You note that there is some evidence in the TMF that the CRO has conducted periodic reviews, but you don’t find any evidence that Penn Pharmaceuticals has conducted any.
•Just as you digest that issue, you receive a request from one of your colleagues that a study team member on another of your studies needs to upload a document to the eTMF but doesn’t know how to navigate the system or classify documents. Assisting study team members with training and support in the eTMF is one of your standard responsibilities.
•You are due to meet with Ann, your Line Manager, for your scheduled 1:1 in an hour; you know she will want an update on all things project related. Ann doesn’t just like to hear problems; she wants solutions and ideas to overcome problems. You know that all your assigned studies are high on the radar for Penn Pharmaceuticals and that Ann must provide an update in her weekly call with the Leadership team which meets at the end of the week.
1. What immediate steps will you take across the three priorities?
How will you present necessary information?
2. How will you address the deficiencies that you noted on 96731 to keep the QC deliverable on track?
3. How will you manage the escalation of FDA submission 54139?
What recommendations will you make to begin inspection readiness activities to prepare the TMF?
4. How do you show Ann that you have the skills and confidence to provide study statuses to your 1-1s and leverage her mentorship and guidance to help you be successful?
What risks can you identify and how would you mitigate those risks?
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