Description:
Our small biotech company is looking for a Clinical Data Manager to support their ex-US study for liver cancer and solid tumors. They previously had a CRO who has handling all of their data, but they have dropped the ball. They are going to change CRO’s and hope that this Data Manager can help participate in selecting a new CRO and review their proposal requirements (especially the data management portion.) They are conducting an international study and currently preparing for a Database Lock. They need this person to help with the database lock and analysis for an IND submission into the FDA to have their study conducted in the US. How their submission is received will determine the workload and longevity of this project. This individual will be responsible for the EDC set up and data review. They will be reviewing manual and listing reviews from the Biostatisticians. They will be acting as the oversight and provide crucial documentation to the newly selected CRO. Experience being a Data Manager with numerous studies is imperative and would be beneficial for someone who worked on oncology and/or Gene Therapy. The current CRO has an old EDC they use, so they will be using whatever EDC their new CRO uses (hopefully Medidata, Veeva, etc.) They will be responsible for reviewing the data in Excel. They will be cross functionally working hand in hand with Clinical Operations, CRO, Statistics, and their Regulatory departments.
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