Senior Clinical Project Manager

Fortvita Biologics is a biopharmaceutical company focused on advancing next-generation biologics to address critical health needs. The Senior Clinical Project Manager will oversee the planning, execution, and delivery of oncology clinical trials, ensuring they are completed on time, within scope, and in compliance with regulatory standards.

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:

• Bachelor's degree in Life Sciences or related field required; advanced degree (MS, PharmD, PhD) a plus
• 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.'