Project Manager

• Manage clinical research studies in accordance with approved scope of work/budget, ICH GCP guidelines, FDA regulations, and established timelines
• Serve as study lead and primary contact for sponsors
• Manage clinical study functions including investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory
• Generate and present study status updates and reports to sponsors
• Supervise and support Clinical team members, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates
• Supervise and train Associate Project Managers
• Create and review clinical study documents, protocols, ICF templates, study budgets, site logs/forms, study manuals and plans, and site binders
• Drive clinical teamwork and communications to achieve trial milestones
• Ensure accuracy of reports and work products
• Provide monthly billing information to the finance team
• Present at investigator meetings and new client meetings
• Update management through frequent communication
• Identify issues and develop problem-solving strategies to meet study timelines
• Manage subject accrual, retention, and compliance
• Assist with TMF management and conduct TMF reviews as needed
• Prepare for and participate in third-party audits and FDA inspections
• Ensure compliance with ICH GCP guidelines, FDA regulations, and company SOPs
• Participate in internal, client/sponsor, scientific, and other meetings
• Perform additional duties as assigned

• BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience
• 3 years of experience in the pharmaceutical / biotechnology / CRO industry with 1 year of management experience
• Proven ability to be careful, thorough, and detail-oriented
• Strong organizational skills and ability to multi-task and work effectively in a fast-paced environment
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• Self-starter who thrives in a collaborative, less structured team environment
• Ability to problem-solve unstructured or ambiguous challenges
• Strong command of English, written and verbal
• Excellent communication and interpersonal skills with customer service orientation
• Proficient with MS Office Suite, particularly Word and Excel