Clinical Research Coordinator
- The Immuno-Oncology (IO) Clinical Project Coordinator is a member of the Immuno-Oncology Global Medicines (GMD) group.
- The IO Project Coordinator will work with a cross-functional team of experts to develop and maintain a web portal, database and robust process for the Toxicity Management Guidelines (TMGs) used across the IO Program.
- The individual in this role will liaise with IO project teams, the IO Lead Safety Physician, IT, external vendors, colleagues from the Site Management & Monitoring (SM&M) organization, and external investigational sites across the world. This role could be broadened in future to include other IO processes.
- Work with IT to develop the website, associated applications and training materials that will be used by IO project teams and external investigators
- Maintain the database
- Add/remove investigator sites and maintain information on who has access to web portal
- Grant accesses to the portal based on IRB and Regulatory approval dates
- Develop communication plan and ensure it is followed
- Work collaboratively with key stakeholders such as IT, SM&M, and external vendors to identify a robust process for communicating changes in the database
- Link with the IO Lead Safety Physician and other key stakeholders to ensure proper exchange of information and a common understanding of expectations
- Develop and maintain the process, perform gap analyses and propose process improvements
- Education Undergraduate degree
- General knowledge of the drug development process
- Database/process management experience in complex, multi-disciplinary environment
- Experience of working collaboratively in global, multi-cultural teams
- Proven ability to transition between roles effectively and learn rapidly in a new environment
- Experience of building processes and conducting gap analyses
- Experience in using databases and process maintenance
- Experience of using CTMS databases (eg IMPACT)