RTSM Specialist managing clinical trial randomization systems for Worldwide Clinical Trials, a global CRO. Overseeing study design, project delivery, budgets, and clinical trial implementations.
Responsibilities
Manage successful implementation of assigned RTSM systems or amendments according to client requirements, agreed time and cost frameworks, and company standards
Provide project management oversight from award through RTSM decommissioning
Oversee deliverables, timelines, and completion of work to Worldwide SOP standards
Communicate RTSM project activities to internal and sponsor study teams
Serve as escalation point of contact for assigned study-related project issues
Coordinate timely delivery of project communications, including study status reports, meeting agendas and minutes, and project call scheduling
Travel to Investigator Meetings or other project-related meetings when required
Manage overall RTSM project budget and ensure accurate vendor work orders
Manage overall RTSM study design
Write, review, and approve User Requirements Specifications (URS)
Requirements
Ability to communicate concisely and effectively in both written and spoken English
Proficient client-facing skills
Proficient in the use of common office software
Self-motivated individual who can positively contribute to a team environment
High attention to detail
Ability to prioritize and handle multiple projects simultaneously
Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
Minimum 2 years prior RTSM experience
Minimum 1 year prior project management experience
Minimum of 5 years experience within CRO /pharma environment
Contract Research Organization (CRO) or Pharmaceutical experience required
Familiar with RTSM topics, including RTSM study design, randomization methodologies, and just-in-time drug supply
Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations
Proven ability to manage delivery of RTSM solutions deployed in clinical trials
Benefits
Competitive benefits package depending on location
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