RTSM Manager - Medidata Balance

As a Randomization & Trial Supply Manager (RTSM) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Delivering Excellence and Quality for Studies in a Diverse Portfolio

Accountable for the User Acceptance Testing (UAT) process for IRT systems. Through UAT, you will be key to the clinical trial process by are ensuring quality and proper functionality in a highly critical system. While following an established process, you’ll also be expected to make suggestions and deploy new ways of working that create efficiencies while maintaining effectiveness.  We are therefore seeking candidates with a unique mix of experience and openness to improvements.

The job tasks will include:

• • • While working with the study-responsible RTSM Manager, develop an understanding of IRT requirements for the trial
    • Apply that understanding of the requirements and trial to create a Testing Plan and Tests that will rigorously stress the IRT system built by the IRT suppliers
    • Demonstrate sufficient knowledge of randomization and medication assignment processes to be able to perform required un-blinded assessments of the IVR/IWR system performance (or functionality) should that be assigned
      
    • Identify and resolve issues identified during the testing process
    • Create and store documentation of these tasks
    • Track trends identified in UAT with the goal of identifying problematic areas that can be proactively addressed to prevent recurrence

You are:

• At least 5 years operational experience in clinical trials with a pharmaceutical company and/or a Clinical Research Organization is required
• Strong knowledge of the clinical trial process, especially with randomization and trial supply management (RTSM) activities and systems
• Experience with testing or validation activities in the clinical trial environment
• Experience with IVRS/IWRS suppliers is preferred
• End to End experience for IRT system builds
• Project Management experience a plus.
• Accountable for system development.
• Vendor mangament experience. 
• Ability to identify issues and problem solve independently while in a complex environment
• BA/BS degree required. 

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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