Senior Clinical Project Manager

Fortvita Biologics is a biopharmaceutical company developing next-generation biologics across oncology, cardiovascular and metabolic diseases, immunology, and ophthalmology. The Senior Clinical Project Manager will lead the planning, execution, and delivery of oncology clinical trials from Phase I through III, overseeing clinical operations, CROs, vendors, timelines, budgets, risk mitigation, and regulatory compliance.

Responsibilities:

• Independently lead the operational execution of oncology clinical trials from startup through close-out
• Serve as the primary point of contact for internal teams and external partners, including monitor team, CROs, vendors, and clinical sites
• Develop and maintain detailed project timelines, operational plans, budgets, and risk mitigation strategies
• Support protocol development, informed consent forms, site feasibility assessments, and study document creation/review/update/archive
• Drive site engagement and issue resolution, collaborating closely with the Medical Monitor, Regulatory, Clinical Supply, Central Sample Management and Data Management team ect
• Manage and oversee CROs and vendors, ensuring quality and performance against contractual obligations and timelines
• Facilitate cross-functional clinical study team meetings, ensure documentation of decisions and follow-up actions
• Contribute to the development and continuous improvement of SOPs, tools, and operational best practices
• Assist in preparation for regulatory inspections and submission of INDs/NDAs
• Provide leadership in a hands-on, resource-limited environment, balancing strategic thinking with operational execution
• Other duties as assigned

Requirements:

• Applicants must have legal authorization to work in the United States
• Bachelor's degree in Life Sciences or related field required
• 5+ years of clinical operations experience, with at least 3 years managing oncology trials
• Experience in managing cross-functional, global clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities
• Demonstrated experience in vendor and CRO oversight, including contracts, budgets, and performance management
• Strong understanding of FDA, EMA, ICH-GCP guidelines, and clinical development processes
• Effective leadership, communication, organizational, and interpersonal skills within small-team environments
• Ability to manage multiple projects and pivot quickly in a fast-paced, evolving setting
• Proficiency with CTMS, EDC systems, and Microsoft Office Suite
• Self-starter mindset with a collaborative spirit and willingness to “roll up your sleeves.”
• Communication
• Problem-solving
• Collaboration
• Time management
• Attention to detail
• advanced degree (MS, PharmD, PhD) a plus