RTSM Specialist
Multiple Locations: United States • Raleigh, NC, USA • United Kingdom
Notice
Requisition Number: 5643
Position Title: RTSM Specialist
External Description:
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 3,000 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.
RESPONSIBILITIES:
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
• Facilitates 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.
OTHER SKILLS AND ABILITIES:
• 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 problems
• 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
Why Worldwide
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
City:
State:
Employment Type: Regular
Community / Marketing Title: RTSM Specialist
Company Profile:
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
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CountryEEOText_Description: 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 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. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.