RTSM Specialist

Worldwide Clinical Trials; Brasília; Presencial; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

Worldwide Clinical Trials in Brazil is seeking an experienced RTSM Project Manager to lead RTSM programs within our Clinical Systems Department. You will oversee project management from award to decommissioning, coordinate study communications, manage budgets, and ensure compliance with industry standards.

Travel may be required; you will partner with sponsors and internal teams to deliver reliable RTSM solutions across trials.

Qualificações

• Educated to degree level in a relevant discipline.
• Minimum 2 years RTSM experience.
• Minimum 1 year project management experience.
• Minimum of 2 years CRO/pharma experience.
• 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.

Responsabilidades

• 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).
• 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 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 plans and complete user acceptance testing.
• Facilitate sponsor completion of user acceptance testing of system.
• Accountability for monitoring study randomization to ensure correct execution.
• Perform other duties as assigned.

Conhecimentos

Project management

RTSM

Client-facing

English communication

Formação académica

Bachelor's degree or equivalent experience

Ferramentas

MS Office

Descrição da oferta de emprego

Who We Are

We’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 Worldwide

We 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 Clinical Systemsdepartment Does At Worldwide

Our Clinical Systems Department plays an essential role for the entire organization by ensuring our systems are developed to study specifications, fully integrated, optimally running, and well-maintained throughout the studies’ lifecycle. The department works closely with industry-specific systems such as: IRT, RTSM, EDC, RBQM Opra, ClinSpark, eTMF, and CTMS. The department has various roles, including client-facing Project Managers, System and Software Designers, and Implementation and Validation specialists.Each of these areas provides mentorship and training. In working with a variety of systems, the department has a proven record of success for promotions and growth internally.

What You Will Do

Tasks may include but are not limited to:

• 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)
• 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 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 plans and complete user acceptance testing
• Facilitate sponsor completion of user acceptance testing of system
• Accountability for monitoring study randomization to ensure correct execution
• Perform other duties as assigned

What You Will 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
• 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 prior RTSM experience
• Minimum 1 year prior project management experience
• Minimum of 2 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

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.

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.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.