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    Clinical Trial Manager - San Diego, United States - Boundless Bio

    Boundless Bio
    Boundless Bio San Diego, United States

    3 weeks ago

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    Description

    Boundless Bio is a publicly traded (Nasdaq:BOLD), San Diego-based, clinical stage oncology company employing an exciting new area of cancer biology, extrachromosomal DNA ("ecDNA"), to revolutionize the way cancer is treated. Reporting to the Associate Director, Clinical Operations we are seeking a Clinical Trial Manager (CTM) who will be an essential contributor to our BBI-355 program with a strong pipeline following. The successful candidate is an independent self-starter with strong attention to detail. Open to hybrid/remote work schedule.

    Duties and Responsibilities:

    • In partnership with CROs, provide guidance and daily oversight for the successful management of all aspects of global oncology trials
    • Perform operational management of study PK/PD samples and drug supply at study sites for 355
    • Support Associate Director, Clinical Operations for monthly subject accruals
    • Coordinate with legal and follow-up on all outstanding matters for 355 (new contracts, CTAs, CDAs)
    • Tracking/admin support for Lilly & Taiho Clinical Supply Partnerships
    • Monitor the progress of trials including enrollment and clinical trial material inventory
    • Develop protocols, consent forms, IRB/EC materials, and other trial documents
    • Assist in case report form (CRF) development and programming of electronic data capture
    • Participate in the process of site and vendor selection and qualification
    • Prepare or review and approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring reports.
    • Provide study updates at clinical operations meetings-including updating other clinical staff and upper management on patient recruitment, trial issues, investigator's feedback, monitoring issues, patient enrollment issues and presenting a plan of action for resolution of issues
    • Act as cross-functional liaison to ensure study plans remain aligned with current business development strategies.
    • Perform all duties in keeping with the Company's core values, policies and all applicable regulations.
    Education/Experience:
    • Bachelor's degree in a scientific or health related field or equivalent combination of education and experience
    • 5+ years of experience directly supporting clinical research trials or relevant equivalent experience
    • Analytical problem-solving experience, including the ability to anticipate and resolve obstacles with strong reasoning skills
    • Excellent organizational skills and attention to detail
    • Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA regulations
    • Effective communication and interpersonal skills; ability to build relationships internally and externally
    • Cross functional and cross-cultural awareness, someone who seeks out diverse perspectives and considers these perspectives in making decisions
    • Patient-centric philosophy towards research
    • Ability to thrive in an entrepreneurial, fast-paced, and dynamic work environment
    • Familiarity with medical terms
    • Demonstrated writing skills to deliver messages effectively so messages are clearly understood
    • Demonstrated expertise with PCs and standard Microsoft Office software applications
    • Up to 20% travel
    The anticipated annual salary range for this position is $135,000 to $165,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. In addition to base salary, BBI employees are eligible for an annual bonus incentive, and an equity stock option grant. BBI offers a competitive benefits package including, medical, dental, vision, and life insurance for employees and their dependents. We also offer and an Employee Stock Purchase Plan (ESPP) and a 401(k) plan with a matching contribution in addition to a flexible time off policy.

    Boundless Bio fosters an inclusive company culture that values diverse talent, backgrounds, and experiences. We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories.
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