Senior Manager, RTSM Consulting and UAT - multiple EU/UK locations

This position can be flexibly based in multiple EU/UK locations.

The role provides consultation on the Randomization and Trial Supply Management (RTSM) design, analyzing study protocols, and collaborating with stakeholders to create user requirements to meet the needs of the study.  This individual is responsible for identifying and mitigating risks related to RTSM design and ensuring that the overall deliverables align with internal and external client expectations.  In addition, this role provides management of a team conducting User Acceptance Testing (UAT) on RTSM and Digital Health Technology (e.g., eCOA, eConsent) systems.

Main responsibilities:

Project Delivery

• Provide consultation to Project Leaders and other study team members on RTSM study design

• Analyze protocols and collaborate with all stakeholders to create and review user requirements and ensure they meet the needs of the study design

• Identify and mitigate any risks related to RTSM study design

• Translate complex RTSM requirement descriptions into language that can be understood by study team to aid in their decision making and understanding of project functionality

• Understand the various integrations that can interface with the RTSM and proactively help identify any potential integration user requirements issues

• Work closely with UAT Leads

• Stay current on RTSM technology and relevant clinical trial process developments in the industry and requirements within Parexel

Client Management

• Interact with external clients as needed for discussion on RTSM design and protocol elements

• Demonstrate a proactive approach to providing solutions in a timely manner

Staff Development

• Manage and mentor a team of UAT leads to foster growth, teamwork, and empowerment

• Set clear individual and function level goals with effective feedback and recognition of strong performance

• Create an inspirational and inclusive environment to motivate the team to meet and exceed targets and KPIs

• Provide learning opportunities to develop talent

Ideal candidate will possess:

• Fluent English and local language

• Significant work experience in a CRO/Pharma setting including client interaction

• Knowledge in clinical research industry, including expert understanding of clinical technology, RTSM design, and system requirements

• Experience leading and managing global teams 

• eCOA, ePRO experience is a plus

• Extensive experience in RTSM clinical trial systems with detailed understanding of requirements gathering, configuration, design, and user acceptance testing

• Excellent technical and data standard experience

• Proven awareness/experience in the needs and use of data standards in clinical trial environment; if possible, knowledge/experience of data standards such as CDISC SDTM are a plus

• Excellent interpersonal, verbal, and written communication skills

• Client focused and demonstrating an ability to create and maintain trust with the client

• Knowledgeable in ICH and GCP regulations in relevant geographies

• Demonstrated leadership and ability to foster teamwork and drive toward achievement of goals

• University degree in life sciences and/or computer sciences