Clinical Project Manager (m-f-n)
The MedEx Data & Tech project aims to establish the required digital toolset to expedite clinical development by 300 days. In the course of two years more than 10 large global systems are going to be exchanged and innovative analytics tools are being built to support protocol design, trial oversight and clinical data analytics platforms. For that purpose, we seek to augment a skill not present at BI.
The objective is to modernize clinical development and significantly shorten the time to market. That means, reducing the time it takes from first study to market entry by 300 days.
The project will be organized using agile methods. The sprints will be organized depending on product backlog complexity involving the following cadences:
1.) Weekly stand-up meetings. During those, all project managers will be providing an update on the tasks they have worked on during the week. After that, the contractor works iteratively on his tasks. The weekly stand-up meeting takes place one time a week.
2.) Daily stand-up meetings in the individual sprint teams, where the contractor works on the detailed objectives in the required iterations. After that, the contractor works iteratively on his tasks. The team meets briefly each day.
3.) Retrospectives: 1 hour depending on the respective sprint team rhythm to reflect on the outcomes and agree on improvements. After that, the contractor works iteratively on his tasks.
4.) Product Refinement meetings on demand of the specific sub-product. During a product refinement meeting, the team and product owner discuss the top items on the product backlog. After that, the contractor works iteratively on his tasks. The purpose of the product refinement meeting is to continuously update and maintain the product backlog, add new product backlog items and build a common understanding of the product backlog items.
The expertise tasks required during the assignment are:
- Establish clinical operations data and technology-based capabilities based on the results of the project meetings
- Prepare and facilitate workshops with mid/senior level business/IT leadership and drive workshop outcomes to conclusion. When presentations are created, they are reviewed and approved by BI bevor use
- Prepare summaries of the contents of the project meetings for upper management to drive decision making
- Analyze and consult in defining both "To Be" and "As Is" processes and model processes within the area of Clinical Development
- Derive/write User Requirement Specifications for the above products. These User Requirement Specifications are reviewed and approved by BI.
- Perform external research to determine regulatory and legal requirements existing for the process, and applicable industry benchmarks, for the purpose of product development. The results are documented and discussed in meetings