RTSM Specialist

Worldwide Clinical Trials; Durham (NC); On-site; USD 72,000 - 143,000; Full time

Job summary

Worldwide Clinical Trials is seeking an RTSM Specialist to lead the successful implementation of RTSM systems and amendments in line with client requirements, budgets, and SOPs.

You will manage end-to-end RTSM projects, coordinate with sponsors and study teams, monitor timelines and costs, and support URS creation, UAT, and study design. Travel may be required; CRO experience and strong English communication are essential.

Qualifications

• Minimum 2 years of RTSM experience.
• Minimum 1 year of project management experience.
• Minimum of 5 years of experience within a CRO or pharmaceutical environment.
• Familiar with RTSM topics, including RTSM study design, randomization methodologies, and just-in-time drug supply.

Responsibilities

• Provide project management oversight from award to RTSM decommissioning, including deliverables and timelines per SOPs.
• Communicate RTSM activities to stakeholders and sponsor study teams; act as escalation point for issues.
• Maintain accountability for RTSM communications, reports, agendas, and meeting minutes.
• Oversee RTSM budget and vendor work orders; manage URS development and approvals.
• Perform quality control checks and assist with UAT planning and testing.
• Travel to Investigator Meetings or other meetings as required.

Skills

RTSM experience

Project management

English communication

Attention to detail

CRO/pharma experience

Education

Bachelor's degree in a relevant discipline

Tools

MS Office

Excel

Job description

Who we areWe’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!What the RTMS Specialist does at WorldwideManages 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 assignedThe 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 problemsYour 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 trialsPromotion 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.At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):United States of America - $71,500.00 - $142,500.00The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.We love knowing that someone is going to have a better life because of the work we do.To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .