Manager, Data Management

As Senior Manager, Data Management you will be primarily responsible for the direct management of clinical study activities as they relate to data collection and processing from study start up through ongoing oversight to completion. Working in a highly matrixed environment, the successful candidate must have proven ability to effectively manage outsourced vendor activities as well as internal resources., * Develop and review standard Case Report Forms (eCRFs), Data Management Plans, Validation Specifications and Data Transfer Specifications

• Provide Data Management inputs during study protocol development; contribute to the enhancement of a clinical library
• Develop and review standard Case Report Forms (eCRFs), Data Management Plans, Validation Specifications and Data Transfer Specifications
• Provide Data Management inputs during study protocol development; contribute to the enhancement of a clinical library.
• Participate in the development/maintenance of Data Management SOPs, Standard Working Practices, and other Data Management related process documents as needed.
• As appropriate, contribute to the selection, oversight of CRO performance related to Data Management activities; act as the sponsor representative for Data Management outsourced activities.

• A life science BSc with demonstratable experience of Clinical Data Management in pharma/biotech industry
• Experience leading Data Management activities in clinical trials
• Proficient use of Data Management systems with strong knowledge of Data Management processes, tools, methodologies and documentation
• Experience of using Medidata Rave and of supporting Oncology or Neurology clinical trials would be advantageous
• Some experience with line management; mentoring team members (external/contract staff) on Clinical Data Management activities and procedures preferred