Project Management

Project Management is a crucial part of a study’s success. Align CRO employs experienced Project Managers with knowledge in oncology and phase I-II clinical research.

Align CRO and its Project Managers understand the unique and complex situations involved with phase I-II oncology research and use their experience to provide any support, advice, or collaboration that the Sponsor may require to successfully execute a project.

The responsibilities and capabilities of the Project Managers include:

  • Serving as the single point of contact between the Sponsor and Align CRO for any and all questions and concerns

  • Communicating the study’s progress to the Sponsor in an ongoing, regular, and timely fashion

  • Identifying quality issues through close trial oversight and implementing appropriate corrective action plans

  • Managing study from initiation through completion and ensuring all project deliverables are completed

  • Coordinating project-related training throughout the study

  • Coordinating the placement and scheduling of monitor visits

  • Managing contract CRAs and overseeing their work through effective data management

  • Ensuring study compliance with government regulations, guidelines, and industry standards

  • Establishing and maintaining key relationships with contractors and other Align CRO departments to ensure the success of the project

Align CRO Project Managers oversee each study, according to Align CRO SOPs and an agreed upon Study Management Plan. The Project Management plans and services at Align CRO assure that each study is executed as seamlessly and efficiently as possible, while providing the immediate and long term support.