Senior Clinical Data Manager
2 months ago
About This Role
The Senior Clinical Data Managers will serve in a support-level capacity on a Clinical Data Management team to provide efficient and high-quality clinical data management products.
Working closely with the Principal Clinical Data Lead, the Senior CDM will ensure that all Data Management activities (from CRF development to Database Lock and eTMF archival) are performed in line with Biogen's processes.
There are two open roles. These positions can be remote or Hybrid.What You'll Do
Support the design, specification, and development of eCRFs, ensuring adherence to Biogen standards throughout.
Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
Support the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high-quality clinical data.
Support the comprehensive review of all data generated from the clinical study including EDC, Third Party/External data, SAE data and local lab data, as applicable.
With guidance from Principal Clinical Data Lead or Manager, effectively manage project timelines and quality.
Provide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities.
Provide back up support for Principal Clinical Data Lead as required.
Who You Are
You are an experienced, passionate and skilled Clinical Data Manager. You have deep knowledge of CDM processes, EDC systems and Data Review tools.
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