RTSM Project Lead – Global CRO (US/CA)

NCBiotech; Durham (NC); On-site; USD 72,000 - 143,000; Full time

Job summary

Worldwide Clinical Trials is seeking a RTSM Specialist to lead the successful implementation and ongoing management of RTSM systems across studies. You will oversee deliverables, timelines, and budget while ensuring compliance with Worldwide SOPs.

The role requires strong communication with sponsors and internal teams, experience in RTSM study design and randomization, and the ability to travel for Investigator Meetings as needed. A CRO/pharma background is essential.

Qualifications

• 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
• 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 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)

Skills

Project management

RTSM knowledge

Communication skills

Budget management

Vendor coordination

MS Office

Education

Bachelor's degree or equivalent experience

Tools

MS Office

Job description

Worldwide Clinical Trials is seeking a RTSM Specialist to lead the successful implementation and ongoing management of RTSM systems across studies. You will oversee deliverables, timelines, and budget while ensuring compliance with Worldwide SOPs.

The role requires strong communication with sponsors and internal teams, experience in RTSM study design and randomization, and the ability to travel for Investigator Meetings as needed. A CRO/pharma background is essential.