What the RTMS Specialist does at Worldwide

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.

What you will do

• 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

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What you bring to the role

• 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

Your experience

• 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

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.