RTSM Specialist

Worldwide Clinical Trials•Carolina, NC

About The Position

Manages the successful implementation of assigned Randomization and Trial Supply Management (RTSM) systems or amendments in accordance with the client’s requirements, within the time and cost frameworks agreed upon, and to Worldwide Clinical Trials company standards.

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
Flexible and able to use sound independent judgment and take initiative to assess information
Able to make effective decisions in a fast-paced, highly dynamic environment
Able to be creative, adapt to new technologies, concepts, and processes, make improvements, and solve problems
Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
Minimum 2 years of prior RTSM experience
Minimum 1 year of prior project management experience
Minimum of 5 years of experience within a Contract Research Organization (CRO) or pharmaceutical 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

Responsibilities

Provide project management oversight from award to RTSM decommissioning, including oversight and accountability of deliverables and timelines and completion of work to Worldwide Clinical Trials Standard Operating Procedure (SOP) standards
Communicate information on applicable RTSM project activities to stakeholders, including internal and sponsor study teams. Serve as the escalation point of contact for all RTSM assigned study-related project issues
Maintain overall accountability for coordination and timely delivery of RTSM project communications, including study status reports, meeting agendas and minutes, and scheduling project calls
Demonstrate willingness to travel and attend Investigator Meetings or other types of project-related meetings when required
Be responsible for the overall RTSM project budget and ensuring accurate vendor work orders for assigned studies
Be responsible for overall RTSM study design, as well as writing, reviewing, and approving User Requirements Specifications (URS)
Prepare, review, and approve site and support materials, as well as helpdesk documentation, when required
Perform financial review and budget management, including review of change orders
Perform quality control (QC) checks of manual database edits and other tasks where required
Request, receive, and process/upload draft and final subject and kit schedules and inventory release files where required
Create User Acceptance Test (UAT) plans and complete user acceptance testing
Facilitate sponsor completion of user acceptance testing of the system
Maintain accountability for monitoring study randomization to ensure correct execution
Perform other duties as assigned