Job Description

The Senior External Data Specialist (SEDS) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the external data group team members ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team. Scope external study data requirements and effort for projects. Project manage all external data related activities across multiple projects. Provide expert advice on the transfer and expected formats of data transfer files. Provide technological expertise and guidance on the best methods for handling laboratory data and other external data. Create and maintain data transfer agreements. Maintain study documentation within project files as appropriate. Act as primary contact and study representative to third party data providers. Effectively communicate transfer requirements and project timelines to various stakeholders. Identify and communicate project risks. Ensure data integrity is maintained by implementing appropriate data controls for masked data. Ensure delivery of timely data transfers and undertake quality reviews and testing activities. Conduct external data reconciliation using available technologies and processes. Raise queries to external data providers and track queries to successful resolution. Provide listings to medical review team. Assess and implement new data review and analysis processes and technologies. Take a lead role in the development of best practices, process improvement, quality control and governance related to all external data matters. Provide training and mentoring to team members in SOPs, software applications, and best practices. Attributes and Skills-Expert domain knowledge and experience within clinical research and drug development. Advanced knowledge in >1 EDC systems and laboratory processes. Experience mentoring and training others. Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities. Excellent analytical, communication and problem-solving skills. Responsibilities The Senior External Data Specialist (SEDS) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the external data group team members ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team. Scope external study data requirements and effort for projects. Project manage all external data related activities across multiple projects. Provide expert advice on the transfer and expected formats of data transfer files. Provide technological expertise and guidance on the best methods for handling laboratory data and other external data. Create and maintain data transfer agreements. Maintain study documentation within project files as appropriate. Act as primary contact and study representative to third party data providers. Effectively communicate transfer requirements and project timelines to various stakeholders. Identify and communicate project risks. Ensure data integrity is maintained by implementing appropriate data controls for masked data. Ensure delivery of timely data transfers and undertake quality reviews and testing activities. Conduct external data reconciliation using available technologies and processes. Raise queries to external data providers and track queries to successful resolution. Provide listings to medical review team. Assess and implement new data review and analysis processes and technologies. Take a lead role in the development of best practices, process improvement, quality control and governance related to all external data matters. Provide training and mentoring to team members in SOPs, software applications, and best practices. Attributes and Skills Expert domain knowledge and experience within clinical research and drug development. Advanced knowledge in >1 EDC systems and laboratory processes. Experience mentoring and training others. Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities. Excellent analytical, communication and problem-solving skills.