Remote RTSM Specialist — Trial Supply & Study Integrity

Worldwide; Durham (NC); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate RTSM Specialist to support RTSM solutions across UK and US studies. You will coordinate amendments, lead testing efforts, and partner with sponsors and internal teams to uphold data integrity and patient safety in global trials.

The role emphasizes strong communication, meticulous attention to detail, and the ability to manage multiple timelines in a fast-paced environment.

Qualifications

• Minimum 1 year of RTSM experience and at least 2 years in a CRO or pharmaceutical environment.
• 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, with 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, driving 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.

Skills

RTSM knowledge

Stakeholder management

English proficiency

Attention to detail

Time management

Education

Degree in a relevant discipline

Job description

Worldwide Clinical Trials is seeking an Associate RTSM Specialist to support RTSM solutions across UK and US studies. You will coordinate amendments, lead testing efforts, and partner with sponsors and internal teams to uphold data integrity and patient safety in global trials.

The role emphasizes strong communication, meticulous attention to detail, and the ability to manage multiple timelines in a fast-paced environment.