Job Description:
• Provide primary project management oversight for clinical research studies supporting the ACTG Clinical Trials Network
• Manage technical projects or defined portions of larger technical programs in accordance with contract requirements and company policies
• Direct and supervise support resources for project assignments and activities
• Manage technical direction through project design, implementation, and testing
• Oversee project development and implementation as the single point of contact
• Take projects from original concept through final implementation
• Interface with end users, computer services, client services, and all areas affected by projects
• Define project scope and objectives
• Develop work plans, schedules, project estimates, resource plans, and status reports
• Conduct project meetings and track and analyze project progress
• Ensure quality standards and review project deliverables
• Integrate vendor tasks and track and review vendor deliverables
• Provide technical and analytical guidance to the project team
• Direct analysis and solutions for project problems
• Oversee end-to-end clinical trial operations, including study start-up, site coordination, protocol implementation, enrollment tracking, and study close-out
• Maintain responsibility for issue remediation
Requirements:
• Bachelor’s degree in public health, life sciences, health administration, or related field with 4+ years of clinical trial operations experience, or Master’s degree with 2+ years of clinical trial operations experience (listed as preferred)
• Strong knowledge of regulatory requirements, including GCP, ICH, and FDA/NIH guidelines
• Proven ability to manage complex projects collaboratively
• Excellent communication, organizational, and problem-solving skills
• PMP certification preferred
• Experience supporting clinical trials in infectious diseases or related therapeutic areas preferred
• Previous engagement with large, multi-site clinical research programs or networks preferred
Benefits:
• Personal Time Off (PTO)
• Medical insurance
• Dental insurance
• Vision insurance
• Supplemental life insurance with AD&D
• Short-term disability
• Long-term disability
• Flexible spending accounts
• Parental leave
• Legal services
• 401(k) Retirement Plan with matching component
• Training and career development
• Best-in-class e-learning suite for formal and informal learning
• Professional and technical certification preparation
• Education assistance at accredited institutions
• Performance incentives and program-specific awards