CTMS Specialist
OneOncology
OneOncology is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.
Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve.
Job Description:
The CTMS Specialist will collaborate with OneR operations team and OneOncology practices to support clinical research across the OneOncology network. The CTMS Specialist is a vital member of the OneR research team responsible for leading the design, build-out, and deployment of studies within the Clinical Trial Management System (CTMS) within OneR and OneOncology practices. This role involves ensuring that the CTMS is tailored to meet the specific needs of the OneR clinical research teams, optimizing workflows, and maintaining regulatory compliance throughout the system's lifecycle.
Key Responsibilities:
Collaborate with cross-functional teams to define system requirements, workflows, and data structures that support clinical trial operations.
Collaborate closely with the Research Product Manager on all aspects of CTMS.
Deploy research trials within the CTMS system in a timely manner for all impacted OneOncology practices.
Develop and deliver comprehensive training programs for end-users to ensure effective utilization of the CTMS.
Create detailed documentation, including policies, work instructions, etc.
Provide ongoing technical support and troubleshooting for CTMS users, ensuring continuous system performance and user satisfaction.
Serve as the primary liaison between internal teams, external vendors, and stakeholders.
Conduct regular meetings to review progress, gather feedback, and ensure the system meets user needs and regulatory requirements.
Monitor the performance of the CTMS post-implementation, identifying areas for optimization and improvement.
Stay informed of advancements in CTMS technologies and oncology research trends to recommend system enhancements.
Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.
Key Competencies:
Strong understanding of clinical trial processes, regulatory requirements (e.g., ICH-GCP, FDA guidelines), and industry standards
Proficient in interpreting clinical trial protocols, with the ability to understand protocol requirements and translate these into the CTMS
Proficient in interpreting clinical trial budgets, with the ability to ensure the CTMS accurately reflects the approved study budget
Exceptional attention to detail and organizational skills
Excellent communication skills, both verbal and written, with the ability to effectively interact with stakeholders at all levels
Ability to work independently and collaboratively in a fast-paced environment
Excellent problem solving and communication skills
Ability to manage multiple projects and collaborate with diverse teams effectively
Qualifications:
Bachelor’s degree preferred.
At least 3-5 years of experience in oncology research or clinical trials.
Proficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS) preferred
Certification in clinical research (e.g., SOCRA, ACRP) is a plus.
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