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Job Overview

Responsible for activities that support the clinical trial process from start-up to close out. Clinical Operation professionals are tasked with the planning, implementation, management, and execution of the clinical trial process.

• Team Management
  
  
  • Lead, mentor, develop, and manage Clinical Operations Teams, including Clinical Trial Assistants and Clinical Operations Specialists, ensuring optimal team performance and development.
  • Strategically allocate resources across clinical studies, ensuring optimal use of Clinical Trial Assistants and Clinical Operations Specialists based on study demands and timelines.
  • Manage and oversee study start-up activities, ensuring smooth and timely execution of contracts, budgets, and IRB submissions. May work with corporate legal teams as necessary.
  • Monitor project plans, tracking the time required for various clinical tasks to ensure accurate forecasting and resource assignment.
  • Manage tools used throughout the clinical research organization to assess resource load forecasting and utilization of all teams.
  • Ensure the site and lab invoicing process is accurate, timely, and in accordance with contractual agreements.
  • Participate in company initiatives, policies/procedures, continuous improvement initiatives, and share knowledge where applicable.
  • Lead biweekly department team meetings.
  • Help create a fun, rewarding, and collaborative environment.
• Clinical Trial Management System (CTMS)

• Oversee the CTMS, including management of system configuration changes to support evolving study and business needs, ensuring adherence to established change control processes.
• Collaborate with cross-functional teams to set up templates within reports and adjust the eTMF structure within the CTMS to ensure documentation is consistently accurate and audit-ready.
• Collaborate with cross-functional teams to ensure study-specific completeness and accuracy throughout the trial lifecycle, maintaining data integrity, and facilitating effective study tracking and reporting, including archival of documents and data.
• Conduct trainings for the department on new processes, tools, and updates within the CTMS, ensuring alignment with business needs and system capabilities.
• Create and implement best practices for process improvement and tool usage, enhancing team efficiency and system utilization.
• Manage billing for CTMS usage, ensuring accurate tracking of system costs and invoicing, and work with finance teams to reconcile expenses related to the CTMS.

• Bachelor's Degree with a minimum of 5 years of clinical experience at a biotech, pharmaceutical company, site, or clinical CRO
• Previous supervisory/line management experience preferred.
• Experience leading project operational teams through all stages of the trial (forecasting/planning, start-up, conduct, close-out).
• Previous monitoring, study coordination, data management and/or clinical project management experience, including vendor/CRO management is required.
• Advanced knowledge of GCP, ICH and FDA regulatory requirements.
• Ability to motivate and develop team with strong management, analytical and problem-solving skills.
• Must have proficient computer skills with Microsoft Office software (Word, Excel, Project, PowerPoint and Outlook).