Clinical Operations

  • Develop and provide program leaders with initial timelines based on the clinical trial protocol.

  • Identify critical milestones throughout the clinical trial life cycle in collaboration with program leaders.

  • Build and customize tools that integrate site information, patient data, and schedule of assessments. Provide ongoing support and assistance to program leaders in utilizing these tools effectively.

  • Conduct regular quality control checks to ensure up-to-date and accurate information. Collaborate with program leaders to maintain data integrity.

  • Develop enrollment projections that consider screening timelines, holidays, and cohort-specific factors. Provide insights to program leaders on current enrollment rates versus target goals.

  • Establish systems for seamless integration of data between EDC and Veeva TMF systems. Provide guidance and support to program leaders for data integration processes.

  • Utilize data analytics to derive insights, trends, and patterns. Provide program leaders with valuable insights for informed decision-making.

  • Offer continuous support and troubleshooting for the customized tools, providing assistance to program leaders as needed.