Clinical Trials Manager

Durham, NC (Capitola) /
Clinical Operations /
Full-Time
Based in Durham, North Carolina, Xilis, Inc. is a biotechnology company developing a precision oncology platform that guides treatment decisions for oncologists to improve cancer care outcomes for patients and supports drug discovery and development for pharmaceutical companies. Xilis’ proprietary MicroOrganoSpheres (MOS) are miniature patient tumors that capture the full microenvironment and heterogeneity and provide an automated and scalable solution. Using MOS, high-throughput automation, and AI-driven algorithms, Xilis is developing a Xilis Response Score™ for the clinic, enabling oncologists to make informed and timely treatment decisions. Additionally, the MOS technology is speeding up the development and clinical trials of cancer drugs by enabling analysis of authentic tumor microenvironments, high-throughput preclinical modeling, and clinical patient selection capabilities.

We are supported in this mission by top Silicon Valley, New York, and international venture firms that are leaders in the healthcare space and have invested in top precision medicine companies including Foundation Medicine and Guardant Health.

Role Summary
The Clinical Trial Manager (CTM) will oversee all aspects of the execution of Xilis clinical studies ensuring; studies are conducted in accordance with Xilis SOPs and applicable regulations, study data meets quality and integrity requirements, site selection, and performance metrics are met, studies are conducted within established timelines. 

Responsibilities

    • Manage and lead the day-to-day operations of assigned IVD studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
    • Develop and set up critical study documents, plans and systems as appropriate for the product development phase supported by applicable studies
    • Develop risk-based monitoring and project management plans as appropriate for applicable
    • studies
    • Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with study vendor team
    • Manage and lead cross-functional study teams and liaise with other functional areas in order to accurately coordinate clinical study activities
    • Coordinate clinical study timelines with project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
    • Review monitoring visit reports and perform monitoring oversight visits as needed
    • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
    • Lead feasibility assessment and selection of countries and sites for study conduct
    • Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
    • Provide oversight and direction to study team members, including vendors, for study deliverables
    • Coordinate with finance to track the financial status against budget

Requirements

    • BA/BS degree with 3-5 years of clinical trial management experience or advanced degree or (MS/PhD/PharmD) with at least 2 years of clinical trial management experience
    • Strong knowledge of ICH/GCP guidelines
    • Strong knowledge of protocol and clinical drugIVD development processes, clinical study design for IVD development, study planning and management, and risk-based monitoring
    • Strong experience in the management of CROs and other vendors
    • Proven trial management skills and study leadership ability
    • Excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
    • Ability to “roll up your sleeves” and individually contribute results to research and development effort

Desirable

    • Oncology therapeutic experience
Xilis was created when its three founders — an engineer, a physician, and a biologist — decided to come together and commercialize their technology to transform cancer care. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We do not discriminate on the basis of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. Furthermore, even if your work experience isn't perfectly aligned with what we've described above, if you're excited about what we're building then we want to talk to you!
 
Xilis offers comprehensive health, vision, dental & retirement plans, and unlimited PTO. We are a remote-friendly team: our headquarters are in Durham, North Carolina, but we have team members across the US (and beyond!).