RBQM SOLUTIONS ARCHITECT

The RBQM SA actively engages with experts across Parexel in the development of effective ICH GCP compliant RBQM solutions, including the appropriate mix of Central, Remote and On-site monitoring, based on the study specific endpoints, using optimal monitoring modalities for the specific project and planned ability to execute remote monitoring strategies.
This role can be based remotely in a number of European Countries.
The main duties in this role include; Lead the development of viable RBQM strategies for RFP/RFI and partnership accounts that fit study profile, complexity, critical data/processes (endpoints), technology planned and client preferences Actively participate in Quality by Design process, compliant with ICH E8, supporting protocol de-risking and facilitate creation and development of pre-award Risk Assessment (using RACT) including identification of critical data/processes and risk, evaluation of risk and creation of proposed risk control measures Ensure that RBQM strategies meet ICH E6 R2 requirements and Industry standards, align with current industry thinking and comply with Regulatory guidance (e.
., FDA, EMA, MHRA) Co-build and review proposal budgets that incorporate fit-for-purpose RBQM strategies that are operationally sound, while remaining competitive in the marketplace Ensure client responses reflect RBQM strategy discussions, meet client needs, offers consistent messaging, conveys value proposition and critical success factors Support and participate in bid pursuit meetings including development of content; review and integrate content and considerations into Bid strategy as required Develop and rollout RBQM training for other roles engaged in pre-award activities.
Drive proficiency in other roles to articulate RBQM in client interactions including minimum criteria for technology use Support creation of strong One Parexel culture and drive a consultative approach which enables Parexel to develop unique business solutions for its customers Ensure the effective handover and subsequent adoption of RBQM solution to SBU Delivery team via Operational Strategy Handover Maintain efficient knowledge of RBQM solution delivery.
Liaise, as required with operational delivery team to ensure solution sold meets expectation of quality, time, cost, and customer satisfaction Drive lessons learned feedback loop to achieve continual improvement of RBQM solution development Consult with and support, as required, study delivery team/management Skills.
Demonstrates ability to understand, explain and communicate RBQM concepts and supporting technologies.
Experience of RBQM processes and technology Demonstrates understanding and experience with current Parexel technologies and vendor technologies used in support of Parexel processes.
Demonstrates ability to successfully manage a full workload across multiple projects Excellent interpersonal, verbal, and written communication skills (including experience in making presentations at meetings, training sessions) Client focused approach to work Ability to work in a matrix environment and to drive the importance of teamwork.
Excellent negotiation, relationship management, and solutioning skills Strong project management skills Excellent verbal and written communication skills Knowledge and Experience.
Comprehensive understanding of ICH GCP and experience working with all components of RBQM Understanding of risk assessment and evaluation, statistical data analysis and trending Experience working in projects implementing risk based, adaptive monitoring strategies, recommended Experience working in pre-award / proposals environment would be an advantage Education.
Educated to a degree level (biological science, pharmacy or other health related discipline preferred) or relevant clinical, technology or business equivalent Language Skills.
Fluent in written and oral English #LI-REMOTE