Our client is growing at pace due to the success of their Industry leading products for clinical trials. This role is for a Risk Based Monitoring Business Consultant who is a thought leader in centralised and risk based monitoring.

Pop Science are working in Partnership exclusively looking for this Risk Based Monitoring Business Consultant, working with clients who want to apply knowledge and experience to the creation of a leading edge technology for the clinical trials industry.

The Role

The RBM Business Consultant is a critical role working with our customers to implement the client systems for clinical studies.

The role is a client facing role, where the consultant will be required to review study protocols and support client study teams to identify key risk indicators which will support risk-based, centralized monitoring for their study. From this point the implementation 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. Design of the data extraction and aggregation routines which 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 helpful.

Once the study has been released into production, this role will also 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.

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.

Role outline:

• 80% of time will be spent working with the client
• SoW ownership
• Delivering to timescales
• Creation and maintenance of project documentation
• Responsible for project plan, budget and renegotiating statements of works
• Set up kick off meeting
• Support the performance of the protocol risk assessment
• Work with the client to define risk controls including key risk indicators
• Support the client with the development of the centralized monitoring plan
• Performing periodic centralized monitoring review of the Study and Site dashboards to provide insights in study and site risk profile and recommendations for action
• Act as internal stakeholder representing clients/end users as part of the product development cycle.
• Ongoing service support through the study

You will have strong experience in Clinical Data Management and/ or Centralized/Risk Based Monitoring, including consulting with clients/ stakeholders

Interpersonal Skills

· Self-motivated

· Creative and visionary

· Strong communication, ability to make a positive impact with internal and external stakeholders

· Enjoy working in a small, but growing, results-oriented team

· Ability to take responsibility for the consistency and quality of deliverables

Technical Skills (not exclusive)

· Expert understanding of risk-based, centralized monitoring, ideally have worked with this methodology

· Ability to review clinical protocols and understand the study design and subject visits schedules

· Ability to demonstrate and apply critical thinking to KRI and data visualization design and centralized monitoring implementation

· Desire to further develop centralized monitoring process and skills

· Nice to have experience of Software Development Lifecycle, specifically the process of developing requirements

Contact me for more information Henry Grover henry@pop-science.co.uk