[Remote] Clinical Trial Manager – Rare Disease (Remote, U.S. – East Coast Preferred)

Note: The job is a remote job and is open to candidates in USA. Viltis is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. They are seeking an experienced Clinical Trial Manager to manage all aspects of clinical trial execution for global Phase II and III trials, ensuring adherence to GCP and regulatory guidelines while maintaining high-quality trial delivery. Responsibilities • Lead and coordinate global clinical trial activities in compliance with GCP, ICH guidelines, and regulatory requirements • Provide detailed oversight of regional and global trial operations from start-up through close-out • Manage third-party vendors to ensure contracted deliverables are met within quality, arenaflex, and timeline expectations • Collaborate with cross-functional study team members to achieve high-quality deliverables through effective communication, information sharing, and proactive risk management • Monitor trial metrics to ensure performance standards are met by vendors and staff • Develop and maintain detailed project plans, trial documentation, and study status reports for senior leadership • Oversee vendor adherence to contractual obligations and collaborate on change orders as needed • Mentor and provide guidance to assigned CRAs and CTAs, demonstrating leadership and fostering team development • Work closely with Clinical Scientist, Clinical Development Leads, and the study team to support ongoing review of patient profiles and data listings • Proactively identify resource needs and support department-level process improvement initiatives and SOP development Skills • Bachelor's degree in life sciences, healthcare, or related field • Minimum 7+ years of clinical trial management experience within the pharmaceutical or biotechnology industry • Proven experience managing the logistics of global clinical trials, including Phase II and III programs • Demonstrated success overseeing global CROs and specialty vendors • Strong understanding of clinical trial execution, ICH/GCP, and regional regulatory requirements • Exceptional communication, organizational, time management, and conflict-resolution skills • Ability to work independently, anticipate needs, and proactively support colleagues and leadership • Strong critical thinking skills and ability to collaborate effectively in a matrixed environment • Experience working in rare disease or orphan indications • Experience with large, complex global programs and cross-functional project teams • Familiarity with clinical development in infectious or respiratory disease is a plus • Candidates located in East Coast time zones preferred for team alignment Company Overview • Viltis is a consulting firm that engages in the life-science, pharmaceutical, biotech, and medical device industries. It was founded in 2020, and is headquartered in Del Mar, California, USA, with a workforce of 11-50 employees. Its website isApply Now

Apply Now