Associate RTSM Specialist (UK/US)

Worldwide Clinical Trials•Durham, NC
•Remote

About The Position

The Associate RTSM Specialist supports the successful delivery and ongoing operation of Randomization and Trial Supply Management (RTSM) solutions used in clinical trials. The role coordinates system updates, resolves issues, manages timelines, and supports stakeholders throughout the study lifecycle. It works with internal teams, sponsors, and external partners to deliver high-quality solutions while maintaining compliance, data integrity, and patient safety. The specialist takes ownership of live RTSM projects and contributes to clinical trial execution and operational excellence. This remote role is open to candidates based in the UK or US and involves collaboration with global teams across multiple time zones.

Requirements

  • A degree in a relevant discipline or an equivalent combination of education and professional experience.
  • Minimum 1 year of RTSM experience and at least 2 years of experience within a CRO or pharmaceutical environment.
  • Experience working within a Contract Research Organisation (CRO) or pharmaceutical setting.
  • Knowledge of RTSM study design, randomisation methodologies, and just-in-time drug supply processes.
  • Understanding of clinical trial conduct, blinding practices, patient safety requirements, data integrity principles, and applicable regulations.
  • Demonstrated ability to manage and support the delivery of RTSM solutions used in clinical trials.
  • Strong client-facing, communication, and stakeholder management skills.
  • Proficiency in English, strong written and verbal communication skills, excellent attention to detail, and the ability to manage multiple priorities in a fast-paced environment.

Responsibilities

  • Manage RTSM study amendments, ensuring deliverables are completed on time, within scope, and in accordance with established quality standards.
  • Coordinate and communicate RTSM project activities with sponsors, study teams, and internal stakeholders.
  • Serve as the primary escalation point for RTSM maintenance activities and drive issue resolution through to completion.
  • Monitor study randomisation processes to ensure accurate execution and support study integrity.
  • Create and execute User Acceptance Testing (UAT) plans and facilitate sponsor participation in testing activities.
  • Review, prepare, and approve study support materials, helpdesk documentation, and system-related deliverables.
  • Perform financial reviews and support budget management activities related to change orders.
  • Conduct quality control checks, process study schedules and inventory files, and support ongoing operational activities as required.
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