Are you a technical or clinical data manager, who loves building innovative systems, looking for a move into technology? We've got a great Risk Based Quality Management  Consultant role, ideally based in Cambridge.

Our client is growing at pace due to the success of their Industry leading products. We are looking for an Industry leading Implementaion Consultant who wants to apply knowledge and experience to the creation of a leading edge web application for the clinical trials industry.

They are leading global providers of Risk-Based Monitoring (RBM) solutions for clinical trials, and in order to expand its international presence and to keep up with the demand, they need to grow their team.

Role Overview

The RBQM Implementation Consultant is a critical role in our business model, responsible for working with our customers to implement our system RBQM for clinical studies. This role will work alongside the 'RBQM Operations Consultant', developers, testers and validation lead to successfully implement into the client effectively, efficiently and to a high-quality standard.

The role is responsible for ensuring the implementation of the client data into the product and follows a similar process to an EDC study build, which includes design of the KRIs and data sets that will support the central monitors with root cause analysis. The role will also work with the TRI Statistician to review the thresholds for the KRIs. Design of the data extraction and aggregation routines will be required to populate the Study and Site KRI dashboards. Hand over the design to the developer and work with the development team through the build to ensure the ETLs developed meet with the design. Review the build and study set-up with the client prior to validation and user acceptance testing. A good working knowledge of CDISC/CDASH and SDTM standards is essential.

Once the study has been released into production, this role may be responsible for supporting the client study teams during the centralized monitoring cycle to review the KRIs, develop insights into site risks, the risk profile of the study, if risk thresholds need to be adjusted etc. dependent on previous experience.

The Role

You will be responsible for:

• Working alongside the RBQM Operations Consultant, with client study teams to understand the objectives of the study, the study design, subject visits schedule and data sources
• Working with the client study teams to define and design KRIs and supporting data visualizations
• Working with client data teams (DM/Data Ops) to identify the data required from the source system to surface the KRIs in the product.
• Determine thresholds to be utilized for identified KRIs by working with my clients statisticians
• Creating requirement and technical design specifications that define the data extraction and aggregation routines s e.g. what data is required from the source files, what conditions should be met and how it should be transformed and aggregated for use in thr system.
• Working with development during the build cycle to ensure the final SQL stored procedures provide the data required for the Study and Site KRIs dashboards, this will include setting up and running SQL queries.
• Reviewing the product study build with the client and accepting the build as complete before handing over to validation
• Quality of the product study build
• Delivering to timescales
• Creation and maintenance of project documentation
• Potential to perform periodic centralized monitoring review of the Study and Site dashboards to provide insights in study and site risk profile and recommendations for action depending on requirements and experience
• Act as internal stakeholder representing clients/end users as part of the product development cycle.

This is a great opportunity for someone who is interested in how we can make better use of data in clinical trials to determine which sites, patients and data are most at risk with a view to being able to identify the leading indicators that are predictive of study and site quality. While there is a technical component to the build cycle, there is also a great opportunity to gain experience in the practical application of RBM which requires critical thinking.

This role will also be a stakeholder in the future development of my clients product, using the knowledge developed from supporting the study teams to influence the product direction on user features/functions and data models. With this in mind, we are looking for a dynamic and driven consultant, who wants to develop knowledge and experience in using the platform to support ou