Clinical Trial Manager

Main Responsibilities

• Support and/or lead key aspects of clinical trial operations, including vendor management, site start-up, and monitoring activities
• Contribute to the development, review, and maintenance of study documents (e.g., protocols, amendments, informed consent forms, monitoring plans, study manuals, eCRFs, IVRS/IWR systems)
• Foster clear, respectful, and proactive communication between internal teams and external partners, ensuring alignment on study goals and expectations
• Identify, communicate, and help resolve study-related risks and issues in a timely and thoughtful manner
• Support the development, management, and negotiation of clinical site budgets
• Track and support site activation progress, partnering with CROs and internal stakeholders to address barriers and improve timelines
• Review vendor invoices and help monitor for trends or scope changes
• Contribute to monitoring oversight activities, including review of trip reports and monitoring plans
• Support site identification, feasibility assessments, and site selection processes
• Participate in cross-functional project teams and contribute to collaborative decision-making
• Build and maintain strong, respectful relationships with vendors, CROs, and clinical sites
• Support planning and execution of Investigator Meetings and training activities
• Contribute to risk assessment and development of mitigation strategies
• Assist with clinical supplies planning, including forecasting and accountability support
• Ensure accurate and timely filing of study documentation in CTMS and/or eTMF systems
• Support audit and inspection readiness activities
• Ensure compliance with clinical trial registry requirements and applicable SOPs

Education & Experience

• Bachelor’s degree in a relevant field or equivalent combination of education and experience
• Approximately 5+ years of experience in clinical research or clinical operations within biotech, biopharma, or related environments
• Strong organizational and time management skills, with the ability to manage multiple priorities
• Effective communication skills, with the ability to clearly convey information across diverse teams and stakeholders
• Experience contributing to or managing study documentation
• Proactive problem-solving skills and ability to adapt in a dynamic environment
• Working knowledge of ICH/GCP and applicable regulatory guidelines
• Experience working with vendors and cross-functional teams
• Ability to build collaborative, inclusive, and respectful working relationships
• Familiarity with clinical systems such as EDC, IVRS/IWR, CTMS, and Microsoft Office tools
• Commitment to integrity, professionalism, and patient-centered clinical research