RTSM Specialist 12 month contract

Worldwide Clinical Trials; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

Worldwide Clinical Trials is seeking an RTSM Specialist to lead end-to-end RTSM implementations and amendments, ensuring delivery within scope, time and cost constraints. The role requires coordinating study communications, overseeing budgets, and maintaining high-quality documentation across sponsor and internal teams.

The ideal candidate has CRO/pharma experience, RTSM expertise, and the ability to manage multiple projects while traveling as needed to Investigator Meetings and project-related

Qualifications

• Educated to degree level or equivalent experience.
• Minimum 2 years RTSM experience.
• Minimum 1 year project management experience.
• Minimum 5 years experience in CRO/pharma.
• CRO/pharma 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 SOP standards
• Communicates information on RTSM project activities to stakeholders, including internal and sponsor study teams. Serves as escalation point of contact for all RTSM assigned study-related project issues
• Overall accountability for coordination and timely delivery of RTSM project communications including study status reports, meeting agendas and minutes and scheduling project calls
• Willingness to travel and attend Investigator Meetings or other types of project related meetings when required
• Responsible for overall RTSM project budget and ensuring accurate vendor work orders for assigned studies
• Responsible for overall RTSM study design, as well as writing or reviewing and approving User Requirements Specification (URS)

Skills

English communication

Office software

Team collaboration

Attention to detail

Multi-project management

Education

Bachelor's degree or higher

Tools

RTSM software

Job description

What the RTSM Specialist does at Worldwide

Manages the successful implementation of assigned RTSM systems or amendments in accordance with the client’s requirements, within the time and cost frameworks agreed upon and to Worldwide 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 SOP standards
• Communicates information on applicable RTSM project activities to stakeholders, including internal and sponsor study teams. Serves as the escalation point of contact for all RTSM assigned study-related project issues
• Overall accountability for coordination and timely delivery of RTSM project communications including study status reports, meeting agendas and minutes and scheduling project calls
• Willingness to travel and attend Investigator Meetings or other types of project related meetings when required
• Responsible for overall RTSM project budget and ensuring accurate vendor work orders for assigned studies
• Responsible for overall RTSM study design, as well as writing or reviewing and approving User Requirements Specification (URS)

What you will bring to the role

• Ability to communicate concisely and effectively in both written and spoken English
• 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

Your experience

• 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