Fortvita Biologics ยท 1 month ago
Senior Clinical Project Manager
United States
Full-time
Remote
Senior Level
5+ years expFortvita Biologics is a biopharmaceutical company specializing in antibody discovery and engineering, targeting oncology, immunology, and neurodegenerative diseases. They are seeking a Senior Clinical Project Manager to oversee the planning, execution, and delivery of oncology clinical trials across Phase I through III, ensuring compliance with GCP and regulatory standards.
Biotechnology
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
Qualification
Required
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.'
Benefits
Competitive base salary, bonus, and equity for all employees
401(k) retirement plan with employer matching contributions
Comprehensive medical, dental, and vision insurance
Generous paid time off policy, including company holidays and floating holidays
Company
Fortvita Biologics
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase