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Job Title: RTSM Specialist
Job Location: Virtual Argentina
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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 Systems department 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
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
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 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 .
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